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Drugs for Menopausal Symptoms
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
The primary symptoms of menopause are genitourinary
and vasomotor. The genitourinary syndrome
of menopause (GSM) includes symptoms such as
burning, irritation, dryness, dyspareunia, dysuria,
and recurrent...
The primary symptoms of menopause are genitourinary
and vasomotor. The genitourinary syndrome
of menopause (GSM) includes symptoms such as
burning, irritation, dryness, dyspareunia, dysuria,
and recurrent urinary tract infection. Vasomotor
symptoms (VMS; hot flashes, night sweats) often
disrupt sleep.
Tenapanor (Xphozah) for Hyperphosphatemia in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
The FDA has approved the sodium/hydrogen
exchanger 3 (NHE3) inhibitor tenapanor (Xphozah –
Ardelyx) to reduce serum phosphorus in adults with
chronic kidney disease (CKD) on dialysis as add-on
therapy...
The FDA has approved the sodium/hydrogen
exchanger 3 (NHE3) inhibitor tenapanor (Xphozah –
Ardelyx) to reduce serum phosphorus in adults with
chronic kidney disease (CKD) on dialysis as add-on
therapy when phosphate binders are ineffective or
as monotherapy when phosphate binders cannot be
tolerated. Tenapanor is the first NHE3 inhibitor to be
approved in the US for hyperphosphatemia. It was
previously approved as Ibsrela to treat irritable bowel
syndrome with constipation (IBS-C).
Drugs for Acne
The Medical Letter on Drugs and Therapeutics • February 5, 2024; (Issue 1695)
Acne is common among adolescents and adults.
Guidelines for treatment of acne were last published
by the American Academy of Dermatology in...
Acne is common among adolescents and adults.
Guidelines for treatment of acne were last published
by the American Academy of Dermatology in 2016.
Tirzepatide (Zepbound) for Chronic Weight Management
The Medical Letter on Drugs and Therapeutics • December 25, 2023; (Issue 1692)
The injectable glucose-dependent insulinotropic
polypeptide (GIP)/glucagon-like peptide-1 (GLP-1)
receptor agonist tirzepatide, which was approved by
the FDA as Mounjaro for treatment of type 2 diabetes
in...
The injectable glucose-dependent insulinotropic
polypeptide (GIP)/glucagon-like peptide-1 (GLP-1)
receptor agonist tirzepatide, which was approved by
the FDA as Mounjaro for treatment of type 2 diabetes
in 2022, has now been approved as Zepbound (Lilly)
for chronic weight management in adults who have
a BMI ≥30 kg/m2 or a BMI ≥27 kg/m2 and at least
one weight-related comorbidity. The injectable
GLP-1 receptor agonists liraglutide (Saxenda) and
semaglutide (Wegovy) are approved for chronic
weight management in patients ≥12 years old.
Drugs for Depression
The Medical Letter on Drugs and Therapeutics • December 11, 2023; (Issue 1691)
A selective serotonin reuptake inhibitor (SSRI) is
generally used for initial treatment of major depressive
disorder (MDD). A serotonin-norepinephrine reuptake
inhibitor (SNRI), bupropion (Wellbutrin SR,...
A selective serotonin reuptake inhibitor (SSRI) is
generally used for initial treatment of major depressive
disorder (MDD). A serotonin-norepinephrine reuptake
inhibitor (SNRI), bupropion (Wellbutrin SR, and
others), and mirtazapine (Remeron, and others) are
reasonable alternatives. Improvement in symptoms
can occur within the first two weeks of treatment
with these drugs, but a substantial benefit may not be
achieved for 4-8 weeks.
Etrasimod (Velsipity) for Ulcerative Colitis
The Medical Letter on Drugs and Therapeutics • November 27, 2023; (Issue 1690)
The oral sphingosine 1-phosphate (S1P) receptor
modulator etrasimod (Velsipity – Pfizer) has been
approved by the FDA for treatment of moderately to
severely active ulcerative colitis in adults. It is...
The oral sphingosine 1-phosphate (S1P) receptor
modulator etrasimod (Velsipity – Pfizer) has been
approved by the FDA for treatment of moderately to
severely active ulcerative colitis in adults. It is the
second oral S1P receptor modulator to be approved
in the US for this indication; ozanimod (Zeposia) was
the first.
Influenza Vaccine for 2023-2024
The Medical Letter on Drugs and Therapeutics • October 16, 2023; (Issue 1687)
Annual vaccination in the US against influenza A and
B viruses is recommended for everyone ≥6 months
old without a contraindication. Influenza vaccines
that are available in the US for the 2023-2024...
Annual vaccination in the US against influenza A and
B viruses is recommended for everyone ≥6 months
old without a contraindication. Influenza vaccines
that are available in the US for the 2023-2024 season
are listed in Table 2.
Influenza Vaccine for 2023-2024
The Medical Letter on Drugs and Therapeutics • October 16, 2023; (Issue 1687)
Annual vaccination in the US against influenza A and
B viruses is recommended for everyone ≥6 months
old without a contraindication. Influenza vaccines
that are available in the US for the 2023-2024...
Annual vaccination in the US against influenza A and
B viruses is recommended for everyone ≥6 months
old without a contraindication. Influenza vaccines
that are available in the US for the 2023-2024 season
are listed in Table 2.
Osimertinib (Tagrisso) for Adjuvant Treatment of NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • August 7, 2023; (Issue 1682)
The FDA has approved osimertinib (Tagrisso –
AstraZeneca), an oral kinase inhibitor, for adjuvant
treatment of non-small cell lung cancer (NSCLC)
after tumor resection in adults who have epidermal
growth...
The FDA has approved osimertinib (Tagrisso –
AstraZeneca), an oral kinase inhibitor, for adjuvant
treatment of non-small cell lung cancer (NSCLC)
after tumor resection in adults who have epidermal
growth factor receptor (EGFR) exon 19 deletions or
exon 21 L858R mutations. Osimertinib is the first
targeted therapy to be approved in the US for this
indication. The drug was previously approved for
first-line treatment of adults with NSCLC with EGFR
exon 19 deletions or exon 21 L858R mutations and for
treatment of EGFR T790M mutation-positive NSCLC
in adults whose disease progressed on or after EGFR
tyrosine kinase inhibitor therapy.
In Brief: Tafasitamab (Monjuvi) for Diffuse Large B-Cell Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • August 7, 2023; (Issue 1682)
Tafasitamab-cxix (Monjuvi – Morphosys), a CD19-directed cytolytic antibody, has received accelerated
approval from the FDA for use in combination with
lenalidomide (Revlimid) for treatment of relapsed...
Tafasitamab-cxix (Monjuvi – Morphosys), a CD19-directed cytolytic antibody, has received accelerated
approval from the FDA for use in combination with
lenalidomide (Revlimid) for treatment of relapsed or
refractory diffuse large B-cell lymphoma (DLBCL),
not otherwise specified, including DLBCL arising from
low grade lymphoma, in adults who are not eligible
for autologous stem cell transplant. Accelerated
approval was based on overall response rates.
Inspire for Obstructive Sleep Apnea
The Medical Letter on Drugs and Therapeutics • July 24, 2023; (Issue 1681)
The FDA recently expanded the eligibility criteria
(see Table 1) for treatment with the surgically
implanted hypoglossal nerve stimulation system
(Inspire Upper Airway Stimulation – Inspire...
The FDA recently expanded the eligibility criteria
(see Table 1) for treatment with the surgically
implanted hypoglossal nerve stimulation system
(Inspire Upper Airway Stimulation – Inspire Medical
Systems). The device has been advertised lately on
radio and television.
COVID-19 Update: Metformin to Prevent Long Covid?
The Medical Letter on Drugs and Therapeutics • May 29, 2023; (Issue 1677)
Results from a double-blind trial suggest that off-label
use of the oral antihyperglycemic drug metformin
in patients with COVID-19 may decrease the risk
of post-acute sequelae of SARS-CoV-2...
Results from a double-blind trial suggest that off-label
use of the oral antihyperglycemic drug metformin
in patients with COVID-19 may decrease the risk
of post-acute sequelae of SARS-CoV-2 infection
("long COVID").
Choice of Contraceptives
The Medical Letter on Drugs and Therapeutics • May 15, 2023; (Issue 1676)
Intrauterine devices (IUDs) and the etonogestrel
implant are the most effective reversible contraceptive
methods available. Hormonal oral contraceptives,
patches, rings, and injectables are also effective...
Intrauterine devices (IUDs) and the etonogestrel
implant are the most effective reversible contraceptive
methods available. Hormonal oral contraceptives,
patches, rings, and injectables are also effective in
preventing pregnancy. When used alone, barrier and
behavioral methods generally have higher failure
rates than other methods (see Table 1). Selection of
a contraceptive method is usually based on patient-specific factors and personal preference
Vibrant – An Oral Vibrating Capsule for Chronic Idiopathic Constipation
The Medical Letter on Drugs and Therapeutics • May 1, 2023; (Issue 1675)
The Vibrant orally administered vibrating capsule
(Vibrant Gastro), an FDA-cleared medical device, is
now available by prescription for treatment of adults
with chronic idiopathic constipation (CIC) who...
The Vibrant orally administered vibrating capsule
(Vibrant Gastro), an FDA-cleared medical device, is
now available by prescription for treatment of adults
with chronic idiopathic constipation (CIC) who have
not experienced relief of their bowel symptoms
by using laxative therapies at the recommended
dosage for at least one month. It is the first drug-free
treatment to be authorized by the FDA for this
indication.
Altuviiio – A Longer-Acting Factor VIII Product for Hemophilia A
The Medical Letter on Drugs and Therapeutics • May 1, 2023; (Issue 1675)
The FDA has approved Altuviiio (Sanofi), a von
Willebrand Factor (VWF)-independent, recombinant
factor VIII concentrate, for routine prophylaxis, on-demand
treatment to control bleeding episodes,...
The FDA has approved Altuviiio (Sanofi), a von
Willebrand Factor (VWF)-independent, recombinant
factor VIII concentrate, for routine prophylaxis, on-demand
treatment to control bleeding episodes, and
perioperative management of bleeding in children and
adults with hemophilia A. The manufacturer claims that
Altuviiio, which was previously called efanesoctocog
alfa, delivers normal to near-normal factor VIII levels for
most of the week with once-weekly intravenous dosing.
Lenacapavir (Sunlenca) for Multidrug-Resistant HIV
The Medical Letter on Drugs and Therapeutics • May 1, 2023; (Issue 1675)
The FDA has approved oral and injectable
formulations of the HIV-1 capsid inhibitor lenacapavir
(Sunlenca – Gilead) for use with other antiretroviral
drugs to treat multidrug-resistant HIV-1...
The FDA has approved oral and injectable
formulations of the HIV-1 capsid inhibitor lenacapavir
(Sunlenca – Gilead) for use with other antiretroviral
drugs to treat multidrug-resistant HIV-1 infection
(MDR-HIV) in heavily treatment-experienced adults
whose current regimen is failing. Lenacapavir is the
third drug to be approved exclusively for treatment
of MDR-HIV; the intravenously administered CD4-directed antibody ibalizumab-uiyk (Trogarzo) and the
orally administered HIV-1 gp120-directed attachment
inhibitor fostemsavir (Rukobia) were approved earlier.
Cyclosporine Ophthalmic Emulsion (Verkazia) for Vernal Keratoconjunctivitis
The Medical Letter on Drugs and Therapeutics • May 1, 2023; (Issue 1675)
The FDA has approved Verkazia (Santen), a 0.1%
ophthalmic emulsion formulation of the calcineurin
inhibitor cyclosporine, for treatment of vernal
keratoconjunctivitis (VKC). Verkazia is the first
product to...
The FDA has approved Verkazia (Santen), a 0.1%
ophthalmic emulsion formulation of the calcineurin
inhibitor cyclosporine, for treatment of vernal
keratoconjunctivitis (VKC). Verkazia is the first
product to be approved in the US for this indication.
In Brief: Over-the-Counter Narcan Nasal Spray
The Medical Letter on Drugs and Therapeutics • May 1, 2023; (Issue 1675)
The FDA has approved the over-the-counter (OTC)
sale of Narcan (Emergent), a nasal spray that delivers
4 mg of the opioid antagonist naloxone. Narcan nasal
spray has been available by prescription since...
The FDA has approved the over-the-counter (OTC)
sale of Narcan (Emergent), a nasal spray that delivers
4 mg of the opioid antagonist naloxone. Narcan nasal
spray has been available by prescription since 2015
for emergency treatment of opioid overdose. Generic
formulations of Narcan have also been approved; the
manufacturers of these products will be required to
switch them to OTC status and amend their labeling
accordingly. Kloxxado, an 8-mg naloxone nasal
spray, remains available only by prescription.
In Brief: Rezvoglar - Another Insulin Glargine Product Interchangeable with Lantus
The Medical Letter on Drugs and Therapeutics • April 3, 2023; (Issue 1673)
Insulin glargine-aglr (Rezvoglar – Lilly), which was
approved by the FDA as a biosimilar to the reference
product Lantus in 2021 and received interchangeability
status with Lantus in 2022, will become...
Insulin glargine-aglr (Rezvoglar – Lilly), which was
approved by the FDA as a biosimilar to the reference
product Lantus in 2021 and received interchangeability
status with Lantus in 2022, will become available in
the US on April 1, 2023. It is the second biosimilar
insulin product to be designated as interchangeable
with Lantus; Semglee was the first. Rezvoglar did not
receive interchangeability status with Lantus at the
time of its initial approval because the manufacturer
of Semglee had exclusivity for 12 months.
Antiviral Drugs for COVID-19 in Vaccinated Outpatients
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
Three products are currently available in the US for
treatment of high-risk,1 nonhospitalized adults with
mild to moderate COVID-19: oral ritonavir-boosted
nirmatrelvir (Paxlovid), IV remdesivir (Veklury),...
Three products are currently available in the US for
treatment of high-risk,1 nonhospitalized adults with
mild to moderate COVID-19: oral ritonavir-boosted
nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and
oral molnupiravir (Lagevrio). Remdesivir is FDA-approved
for such use; nirmatrelvir/ritonavir and
molnupiravir are available under an FDA Emergency
Use Authorization. Because the pivotal clinical trials
of these products for outpatient use were conducted
in patients who were not vaccinated against
COVID-19, some clinicians have questioned whether
they can benefit vaccinated outpatients.
Live Fecal Microbiota (Rebyota) for Prevention of CDI Recurrence
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
The FDA has approved Rebyota (Ferring), a rectally-administered,
live fecal microbiota suspension, for
prevention of additional recurrences of Clostridioides
difficile infection (CDI) following antibiotic...
The FDA has approved Rebyota (Ferring), a rectally-administered,
live fecal microbiota suspension, for
prevention of additional recurrences of Clostridioides
difficile infection (CDI) following antibiotic treatment
for a recurrent episode of CDI in adults. Rebyota is
the first microbiome-based treatment to be approved
for this indication. It is not approved for initial
treatment of CDI. Fecal microbiota transplantation
(FMT) has been used in patients with multiple
CDI recurrences.
In Brief: Semaglutide (Wegovy) for Weight Loss in Children
The Medical Letter on Drugs and Therapeutics • February 20, 2023; (Issue 1670)
The injectable glucagon-like peptide-1 (GLP-1)
receptor agonist semaglutide (Wegovy), which was
approved by the FDA in 2021 for chronic weight
management in adults, has now been approved for
chronic weight...
The injectable glucagon-like peptide-1 (GLP-1)
receptor agonist semaglutide (Wegovy), which was
approved by the FDA in 2021 for chronic weight
management in adults, has now been approved for
chronic weight management in children ≥12 years old
with an initial BMI in the ≥95th percentile for age and
sex.Semaglutide is also available as Ozempic and
Rybelsus for treatment of type 2 diabetes in adults.
In Brief: Expanded Access to Mifepristone
The Medical Letter on Drugs and Therapeutics • February 20, 2023; (Issue 1670)
First approved in 2000 for termination of pregnancies
of ≤49 days' gestation, the indication for the oral
antiprogestin mifepristone (Mifeprex, and generics)
was expanded in 2016 to include pregnancies...
First approved in 2000 for termination of pregnancies
of ≤49 days' gestation, the indication for the oral
antiprogestin mifepristone (Mifeprex, and generics)
was expanded in 2016 to include pregnancies of
up to 10 weeks' gestation. A single 200-mg oral
dose of mifepristone followed 24-48 hours later by
a single 800-mcg buccal dose of the prostaglandin
analog misoprostol terminates early intrauterine
pregnancies in about 95% of women.
Lecanemab (Leqembi) for Alzheimer's Disease
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
Lecanemab-irmb (Leqembi – Biogen/Eisai), an IV
amyloid beta-directed monoclonal antibody, has
received accelerated approval from the FDA for
treatment of Alzheimer's disease. The label states
that...
Lecanemab-irmb (Leqembi – Biogen/Eisai), an IV
amyloid beta-directed monoclonal antibody, has
received accelerated approval from the FDA for
treatment of Alzheimer's disease. The label states
that treatment with Leqembi should be initiated in
patients with mild cognitive impairment (MCI) or
mild dementia, the population in which the drug was
initiated in clinical trials. Lecanemab is the second
IV amyloid-beta directed monoclonal antibody to be
approved for this indication; aducanumab (Aduhelm)
was approved in 2021 and has the same restrictions
on treatment initiation.
Dupilumab (Dupixent) for Eosinophilic Esophagitis and Prurigo Nodularis
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The FDA has approved the subcutaneously
injected interleukin (IL)-4 receptor alpha antagonist
dupilumab (Dupixent – Sanofi/Regeneron)
for treatment of eosinophilic esophagitis (EoE)
in patients ≥12...
The FDA has approved the subcutaneously
injected interleukin (IL)-4 receptor alpha antagonist
dupilumab (Dupixent – Sanofi/Regeneron)
for treatment of eosinophilic esophagitis (EoE)
in patients ≥12 years old who weigh ≥40 kg and
treatment of prurigo nodularis in adults. Dupilumab
is the first drug to be approved in the US for each
of these indications. It is also FDA-approved for
treatment of atopic dermatitis, asthma, and chronic
rhinosinusitis with nasal polyposis.
Epsolay - A Benzoyl Peroxide Cream for Rosacea
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
Epsolay (Galderma), a 5% benzoyl peroxide cream,
has been approved by the FDA for treatment of
inflammatory lesions of rosacea in adults. It is the first
product containing benzoyl peroxide to be...
Epsolay (Galderma), a 5% benzoyl peroxide cream,
has been approved by the FDA for treatment of
inflammatory lesions of rosacea in adults. It is the first
product containing benzoyl peroxide to be approved
in the US for treatment of rosacea. Benzoyl peroxide
formulations approved for acne have been used off-label
to treat rosacea for years, but itching and burning
have limited their use.
Transdermal Dextroamphetamine (Xelstrym) for ADHD
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The FDA has approved a dextroamphetamine
transdermal patch (Xelstrym – Noven) for once-daily
treatment of attention-deficit/hyperactivity disorder
(ADHD) in patients ≥6 years old. Xelstrym is the...
The FDA has approved a dextroamphetamine
transdermal patch (Xelstrym – Noven) for once-daily
treatment of attention-deficit/hyperactivity disorder
(ADHD) in patients ≥6 years old. Xelstrym is the first
transdermal amphetamine product to be approved
in the US. A methylphenidate transdermal patch
(Daytrana, and generics) has been available for years
for treatment of ADHD.
COVID-19 Update: Evusheld Unlikely to Neutralize XBB.1.5 Omicron Variant (online only)
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The FDA has warned that the investigational long-acting
monoclonal antibodies tixagevimab and
cilgavimab (Evusheld – AstraZeneca) are unlikely
to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2....
The FDA has warned that the investigational long-acting
monoclonal antibodies tixagevimab and
cilgavimab (Evusheld – AstraZeneca) are unlikely
to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2. Evusheld is available under an Emergency Use
Authorization (EUA) for IM pre-exposure prophylaxis of
COVID-19 in persons ≥12 years old who weigh ≥40 kg
and have either a history of a severe adverse reaction
that prevents their vaccination against COVID-19 or
moderate or severe immune compromise.
In Brief: A New Indication for Dabrafenib (Tafinlar) and Trametinib (Mekinist) Combination Therapy (online only)
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The oral kinase inhibitors dabrafenib (Tafinlar – GSK)
and trametinib (Mekinist – Novartis) have received
accelerated approval by the FDA for use together
for a fifth indication: treatment of...
The oral kinase inhibitors dabrafenib (Tafinlar – GSK)
and trametinib (Mekinist – Novartis) have received
accelerated approval by the FDA for use together
for a fifth indication: treatment of unresectable or
metastatic solid tumors with a BRAF V600E mutation
in patients ≥6 years old who have progressed
following prior treatment and have no satisfactory
alternative treatment options. The combination is not
approved for treatment of colorectal cancer because
of known intrinsic resistance to BRAF inhibition and
dabrafenib is not approved for use in patients with
wild-type BRAF melanoma, anaplastic thyroid cancer
(ATC), or solid tumors.
In Brief: Furoscix - A Subcutaneous Furosemide Infusor for Heart Failure
The Medical Letter on Drugs and Therapeutics • January 23, 2023; (Issue 1668)
The FDA has approved Furoscix (scPharmaceuticals),
a subcutaneous formulation of the loop diuretic
furosemide administered via a single-use, on-body
infusor, for treatment of congestion due to...
The FDA has approved Furoscix (scPharmaceuticals),
a subcutaneous formulation of the loop diuretic
furosemide administered via a single-use, on-body
infusor, for treatment of congestion due to fluid
overload in adults with New York Heart Association
(NYHA) Class II-III chronic heart failure (HF).
Furosemide (Lasix, and generics) has been available
for years in oral and IV formulations.
Teplizumab (Tzield) to Delay Onset of Type 1 Diabetes
The Medical Letter on Drugs and Therapeutics • January 9, 2023; (Issue 1667)
Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the
FDA to delay the onset of stage 3 type 1 diabetes
in patients ≥8 years old who have stage 2 type...
Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the
FDA to delay the onset of stage 3 type 1 diabetes
in patients ≥8 years old who have stage 2 type 1
diabetes. It is the first drug to become available in the
US that delays the onset of type 1 diabetes.
In Brief: Oral Minoxidil for Hair Loss
The Medical Letter on Drugs and Therapeutics • December 26, 2022; (Issue 1666)
Topical minoxidil (Rogaine, and others), which is
available over the counter, has been used for treatment
of hair loss in men and women for more than 30 years.
Recently published trials suggest that...
Topical minoxidil (Rogaine, and others), which is
available over the counter, has been used for treatment
of hair loss in men and women for more than 30 years.
Recently published trials suggest that off-label use of
a low dose of oral minoxidil may also be effective.
Margetuximab (Margenza) for HER2-Positive Breast Cancer (online only)
The Medical Letter on Drugs and Therapeutics • November 28, 2022; (Issue 1664)
The FDA has approved margetuximab-cmkb
(Margenza – MacroGenics), a HER2/neu receptor antagonist,
for use in combination with chemotherapy
for treatment of metastatic human epidermal growth
factor receptor...
The FDA has approved margetuximab-cmkb
(Margenza – MacroGenics), a HER2/neu receptor antagonist,
for use in combination with chemotherapy
for treatment of metastatic human epidermal growth
factor receptor 2 (HER2)-positive breast cancer in
adults who received ≥2 prior anti-HER2 regimens, at
least one of which was for metastatic disease.
Mobocertinib (Exkivity) for Non-Small Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • November 28, 2022; (Issue 1664)
Mobocertinib (Exkivity – Takeda), an oral kinase
inhibitor, has received accelerated approval from the
FDA for treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) with...
Mobocertinib (Exkivity – Takeda), an oral kinase
inhibitor, has received accelerated approval from the
FDA for treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) with epidermal
growth factor receptor (EGFR) exon 20 insertion
mutations in adults whose disease has progressed on
or after platinum-based chemotherapy. Accelerated
approval was based on the overall response rate and
duration of response. Mobocertinib is the second
drug to become available in the US for this indication;
the IV EGFR-MET bispecific antibody amivantamab
(Rybrevant) was approved earlier.
Alpelisib (Vijoice) for PIK3CA-Related Overgrowth Spectrum (online only)
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
The oral kinase inhibitor alpelisib (Vijoice – Novartis)
has been approved by the FDA for treatment of
patients ≥2 years old with severe manifestations of
PIK3CA-related overgrowth spectrum (PROS)...
The oral kinase inhibitor alpelisib (Vijoice – Novartis)
has been approved by the FDA for treatment of
patients ≥2 years old with severe manifestations of
PIK3CA-related overgrowth spectrum (PROS) who
require systemic treatment. Alpelisib is the first
drug to be approved in the US for this indication.
It was also approved in 2019 as Piqray for use in
combination with fulvestrant for treatment of certain
types of breast cancer.
Amivantamab (Rybrevant) for Non-Small Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET
bispecific antibody, has received accelerated
approval from the FDA for IV treatment of locally
advanced or metastatic non-small cell lung...
Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET
bispecific antibody, has received accelerated
approval from the FDA for IV treatment of locally
advanced or metastatic non-small cell lung cancer
(NSCLC) with epidermal growth factor receptor
(EGFR) exon 20 insertion mutations in adults whose
disease has progressed on or after platinum-based
chemotherapy. It is the first bispecific antibody
to become available in the US for this indication.
Accelerated approval of the drug was based on the
overall response rate and duration of response.
Idecabtagene Vicleucel (Abecma) for Multiple Myeloma (online only)
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
The FDA has approved idecabtagene vicleucel
(Abecma – BMS), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, for
treatment of relapsed or refractory multiple myeloma...
The FDA has approved idecabtagene vicleucel
(Abecma – BMS), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, for
treatment of relapsed or refractory multiple myeloma in
adults who received ≥4 prior lines of therapy, including
a proteasome inhibitor, an immunomodulatory drug,
and an anti-CD38 monoclonal antibody. Abecma is
an individualized cellular product prepared from the
patient’s own T cells, which are genetically modified
to express chimeric antigen receptors (CAR) and
then infused back into the patient. Ciltacabtagene
autoleucel (Carvykti), another CAR T-cell product, is
also available for the same indication.
Neratinib (Nerlynx) for Metastatic HER2-Positive Breast Cancer (online only)
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
The oral tyrosine kinase inhibitor neratinib (Nerlynx –
Puma Biotechnology) has been approved by the FDA
for use in combination with capecitabine (Xeloda, and
generics) for treatment of advanced or...
The oral tyrosine kinase inhibitor neratinib (Nerlynx –
Puma Biotechnology) has been approved by the FDA
for use in combination with capecitabine (Xeloda, and
generics) for treatment of advanced or metastatic
human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior
anti-HER2-based regimens for metastatic disease.
It was previously approved for use as monotherapy
for extended adjuvant treatment of adults with early-stage,
HER2-positive breast cancer following adjuvant
trastuzumab (Herceptin)-based therapy. HER2 is
overexpressed in about 20% of breast cancers. Up
to 30% of early-stage, HER2-positive breast cancer
cases treated with trastuzumab-based adjuvant
therapy recur. Neratinib is the only HER2-directed
small molecule approved for treatment of early-stage
and metastatic HER2-postive breast cancer.
A New Indication for Axicabtagene Ciloleucel (Yescarta) (online only)
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
The FDA recently approved axicabtagene ciloleucel
(Yescarta – Kite), a CD19-directed genetically
modified cellular product, for treatment of large B-cell
lymphoma that is refractory to first-line...
The FDA recently approved axicabtagene ciloleucel
(Yescarta – Kite), a CD19-directed genetically
modified cellular product, for treatment of large B-cell
lymphoma that is refractory to first-line chemoimmunotherapy
or that relapses within 12 months
of first-line treatment. It was previously approved for
treatment of relapsed or refractory B-cell lymphoma
after ≥2 lines of systemic therapy and for treatment
of relapsed or refractory follicular lymphoma
after ≥2 lines of systemic therapy. Yescarta is an
individualized cellular product prepared from the
patient's own T cells, which are genetically modified
to express chimeric antigen receptors (CAR) and then
infused back into the patient.
Teclistamab-cqyv (Tecvayli) For Multiple Myeloma (online only)
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
Teclistamab-cqyv (Tecvayli – Janssen), a bispecific
B-cell maturation antigen (BCMA)-directed CD3
T-cell engager, has been granted accelerated
approval by the FDA for treatment of relapsed or
refractory...
Teclistamab-cqyv (Tecvayli – Janssen), a bispecific
B-cell maturation antigen (BCMA)-directed CD3
T-cell engager, has been granted accelerated
approval by the FDA for treatment of relapsed or
refractory multiple myeloma in adults who received
≥4 prior lines of therapy, including a proteasome
inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval
was based on response rate. Teclistamab is the first
bispecific BCMA-directed CD3 T-cell engager to be
approved in the US.
Lurbinectedin (Zepzelca) for Small-Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
The alkylating agent lurbinectedin (Zepzelca – Jazz)
has received accelerated approval from the FDA
for treatment of metastatic small-cell lung cancer
(SCLC) in adults with disease progression on or...
The alkylating agent lurbinectedin (Zepzelca – Jazz)
has received accelerated approval from the FDA
for treatment of metastatic small-cell lung cancer
(SCLC) in adults with disease progression on or after
platinum-based chemotherapy. Accelerated approval
was based on the overall response rate and duration
of response. About 13-15% of lung cancers are small-cell
cancers. Most SCLCs occur in patients who are
current or former smokers.
COVID-19 Update: Novavax Vaccine Authorized for Booster Immunization (online only)
The Medical Letter on Drugs and Therapeutics • October 31, 2022; (Issue 1662)
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include its use as a first booster dose in adults
who completed a primary...
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include its use as a first booster dose in adults
who completed a primary series with any COVID-19
vaccine ≥6 months previously and are unable or
unwilling to receive a booster dose of a bivalent mRNA
vaccine. The Novavax vaccine is not authorized for
use in persons who have received a booster dose of
any other COVID-19 vaccine.
Two Vonoprazan Combinations (Voquezna) for H. pylori
The Medical Letter on Drugs and Therapeutics • October 31, 2022; (Issue 1662)
The FDA has approved vonoprazan, a potassium-competitive
acid blocker, copackaged with amoxicillin
(Voquezna Dual Pak – Phathom) and with amoxicillin
and clarithromycin (Voquezna Triple Pak) for
treatment...
The FDA has approved vonoprazan, a potassium-competitive
acid blocker, copackaged with amoxicillin
(Voquezna Dual Pak – Phathom) and with amoxicillin
and clarithromycin (Voquezna Triple Pak) for
treatment of Helicobacter pylori infection in adults.
Vonoprazan is the first potassium-competitive acid
blocker to be approved in the US. It has been available
in Japan for treatment of various acid-related
disorders since 2014. Vonoprazan is not available
alone in the US.
Two New Oral Testosterone Products for Hypogonadism
The Medical Letter on Drugs and Therapeutics • October 31, 2022; (Issue 1662)
The FDA has approved two new oral formulations
of testosterone undecanoate — Kyzatrex (Marius)
and Tlando (Antares) — for treatment of males
with a deficiency of endogenous testosterone
due to...
The FDA has approved two new oral formulations
of testosterone undecanoate — Kyzatrex (Marius)
and Tlando (Antares) — for treatment of males
with a deficiency of endogenous testosterone
due to conditions such as Klinefelter syndrome,
orchiectomy, toxic damage from chemotherapy or
alcohol, or pituitary-hypothalamic injury caused
by tumors, trauma, or radiation. Jatenzo, another
oral testosterone undecanoate formulation, was
approved for the same indication in 2019. No
testosterone products are approved for treatment of
low testosterone levels due solely to aging.
Phosphodiesterase-5 Inhibitors for Alzheimer's Disease?
The Medical Letter on Drugs and Therapeutics • October 31, 2022; (Issue 1662)
A reader asked us to review use of the
phosphodiesterase-5 (PDE5) inhibitor sildenafil for
treatment of Alzheimer's disease...
A reader asked us to review use of the
phosphodiesterase-5 (PDE5) inhibitor sildenafil for
treatment of Alzheimer's disease (AD).
In Brief: OTC Azelastine Nasal Spray 0.15% (Astepro Allergy) for Allergic Rhinitis
The Medical Letter on Drugs and Therapeutics • October 31, 2022; (Issue 1662)
The 0.15% nasal spray formulation of the H1-
antihistamine azelastine hydrochloride (Astepro
Allergy; Children's Astepro Allergy – Bayer) is now
available over the counter (OTC) for temporary relief
of...
The 0.15% nasal spray formulation of the H1-
antihistamine azelastine hydrochloride (Astepro
Allergy; Children's Astepro Allergy – Bayer) is now
available over the counter (OTC) for temporary relief
of nasal congestion, runny nose, sneezing, and itchy
nose due to allergic rhinitis in adults and children
≥6 years old. It is the first intranasal antihistamine
to be approved by the FDA for OTC use. Other drugs
that are available OTC for treatment of allergic rhinitis
symptoms include oral antihistamines, intranasal
corticosteroids, and mast cell stabilizers.
Ruxolitinib Cream (Opzelura) for Nonsegmental Vitiligo
The Medical Letter on Drugs and Therapeutics • October 3, 2022; (Issue 1660)
The 1.5% cream formulation of the Janus kinase
(JAK) inhibitor ruxolitinib (Opzelura – Incyte) has
been approved by the FDA for topical treatment of
nonsegmental vitiligo (NSV) in patients ≥12 years...
The 1.5% cream formulation of the Janus kinase
(JAK) inhibitor ruxolitinib (Opzelura – Incyte) has
been approved by the FDA for topical treatment of
nonsegmental vitiligo (NSV) in patients ≥12 years old.
Opzelura is the first product to be approved by the
FDA for this indication. It was previously approved for
treatment of atopic dermatitis.
COVID-19 Update: Bivalent Pfizer and Moderna COVID-19 Vaccines for Booster Immunization
The Medical Letter on Drugs and Therapeutics • October 3, 2022; (Issue 1660)
The FDA has amended its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to permit use of bivalent
formulations of the...
The FDA has amended its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to permit use of bivalent
formulations of the products as a single booster dose
in persons ≥12 years old (Pfizer) or ≥18 years old
(Moderna) whose most recent COVID-19 vaccine dose
was a monovalent product given ≥2 months previously
as a booster or for completion of a primary series. The
bivalent formulations are not authorized for primary
immunization. Monovalent Pfizer and Moderna
COVID-19 vaccines are no longer authorized for use as
booster doses in persons ≥12 years old.
COVID-19 Update: Novavax Vaccine Authorized for Adolescents 12-17 Years Old (online only)
The Medical Letter on Drugs and Therapeutics • October 3, 2022; (Issue 1660)
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include use of the vaccine as a two-dose primary
series in adolescents...
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include use of the vaccine as a two-dose primary
series in adolescents 12-17 years old. The vaccine
was authorized for primary immunization of adults in
July 2022.
Prevention and Treatment of Monkeypox
The Medical Letter on Drugs and Therapeutics • September 5, 2022; (Issue 1658)
An outbreak of monkeypox has recently spread around
the globe and across the US. Updated information
about the current outbreak is available from the...
An outbreak of monkeypox has recently spread around
the globe and across the US. Updated information
about the current outbreak is available from the CDC.
Baricitinib (Olumiant) for Severe Alopecia Areata
The Medical Letter on Drugs and Therapeutics • September 5, 2022; (Issue 1658)
The oral Janus kinase (JAK) inhibitor baricitinib
(Olumiant – Lilly), which was previously approved by
the FDA for treatment of moderately to severely active
rheumatoid arthritis and treatment of COVID-19...
The oral Janus kinase (JAK) inhibitor baricitinib
(Olumiant – Lilly), which was previously approved by
the FDA for treatment of moderately to severely active
rheumatoid arthritis and treatment of COVID-19 in
certain hospitalized adults, has now been approved
for treatment of severe alopecia areata in adults.
Baricitinib is the first systemic treatment to be
approved in the US for this indication.
Nalmefene Returns for Reversal of Opioid Overdose
The Medical Letter on Drugs and Therapeutics • September 5, 2022; (Issue 1658)
The FDA has approved a generic injectable formulation
of the opioid antagonist nalmefene (Purdue) for the
management of known or suspected opioid overdose.
Revex, the reference product, was withdrawn from...
The FDA has approved a generic injectable formulation
of the opioid antagonist nalmefene (Purdue) for the
management of known or suspected opioid overdose.
Revex, the reference product, was withdrawn from the
market in 2008 for commercial reasons.
Upadacitinib (Rinvoq): A Second JAK Inhibitor for Ulcerative Colitis
The Medical Letter on Drugs and Therapeutics • September 5, 2022; (Issue 1658)
The FDA has approved the oral Janus kinase (JAK)
inhibitor upadacitinib (Rinvoq – Abbvie) for treatment
of moderately to severely active ulcerative colitis in
adults who have had an inadequate response to...
The FDA has approved the oral Janus kinase (JAK)
inhibitor upadacitinib (Rinvoq – Abbvie) for treatment
of moderately to severely active ulcerative colitis in
adults who have had an inadequate response to or
cannot tolerate one or more tumor necrosis factor
(TNF) inhibitors. Upadacitinib is the second JAK
inhibitor to be approved for this indication; tofacitinib
(Xeljanz) was the first. Upadacitinib is also approved
for treatment of rheumatoid arthritis, psoriatic
arthritis, atopic dermatitis, and ankylosing spondylitis.
COVID-19 Update: FDA Authorizes Novavax COVID-19 Vaccine
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has issued an Emergency Use Authorization
(EUA) for an adjuvanted protein subunit COVID-19
vaccine manufactured by Novavax. The vaccine
is indicated for use as a two-dose primary series
to prevent...
The FDA has issued an Emergency Use Authorization
(EUA) for an adjuvanted protein subunit COVID-19
vaccine manufactured by Novavax. The vaccine
is indicated for use as a two-dose primary series
to prevent COVID-19 in adults; it is not authorized
for use in children or as a booster dose. Three
other COVID-19 vaccines are available in the US for
primary immunization of adults; the mRNA vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) are FDA-licensed for this indication,
and the adenovirus-based vaccine manufactured
by Johnson & Johnson (Janssen) is available under an
EUA for use in adults who are unable or unwilling to
receive another COVID-19 vaccine.
COVID-19 Update: Dosing Interval for Tixagevimab/Cilgavimab (Evusheld) (online only)
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has amended its Emergency Use
Authorization (EUA) for the investigational long-acting
monoclonal antibodies tixagevimab and
cilgavimab (Evusheld – AstraZeneca) to recommend
repeat dosing every 6...
The FDA has amended its Emergency Use
Authorization (EUA) for the investigational long-acting
monoclonal antibodies tixagevimab and
cilgavimab (Evusheld – AstraZeneca) to recommend
repeat dosing every 6 months in patients who require
ongoing protection against COVID-19. Evusheld
is authorized for IM pre-exposure prophylaxis of
COVID-19 in persons ≥12 years old who weigh ≥40 kg
and have either a history of a severe adverse reaction
that prevents their vaccination against COVID-19 or
moderate or severe immune compromise
Tapinarof Cream (Vtama) for Psoriasis
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has approved Vtama (Dermavant), a 1%
cream formulation of the aryl hydrocarbon receptor
(AhR) agonist tapinarof, for treatment of adults with
plaque psoriasis. It is the first AhR agonist to...
The FDA has approved Vtama (Dermavant), a 1%
cream formulation of the aryl hydrocarbon receptor
(AhR) agonist tapinarof, for treatment of adults with
plaque psoriasis. It is the first AhR agonist to be
approved by the FDA.
Oteseconazole (Vivjoa) for Recurrent Vulvovaginal Candidiasis
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has approved oteseconazole (Vivjoa –
Mycovia), a new oral azole antifungal, to reduce the incidence
of recurrent vulvovaginal candidiasis (RVVC)
in females with a history of RVVC. Oteseconazole...
The FDA has approved oteseconazole (Vivjoa –
Mycovia), a new oral azole antifungal, to reduce the incidence
of recurrent vulvovaginal candidiasis (RVVC)
in females with a history of RVVC. Oteseconazole is
the first drug to be approved in the US specifically for
treatment of RVVC.
A Donepezil Patch (Adlarity) for Alzheimer's Disease (online only)
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
A once-weekly transdermal formulation of the
acetylcholinesterase inhibitor donepezil (Adlarity –
Corium) has been approved by the FDA for
treatment of mild, moderate, and severe Alzheimer's
disease (AD)...
A once-weekly transdermal formulation of the
acetylcholinesterase inhibitor donepezil (Adlarity –
Corium) has been approved by the FDA for
treatment of mild, moderate, and severe Alzheimer's
disease (AD) dementia. Donepezil is the second
acetylcholinesterase inhibitor to become available in
a transdermal formulation; transdermal rivastigmine
(Exelon Patch), which is applied once daily, has been
available for years for the same indication. Donepezil
is also available in oral formulations (Aricept, and
generics) for treatment of AD dementia.
COVID-19 Update: Prescription of Paxlovid by Pharmacists (online only)
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed...
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.
Tezepelumab (Tezspire) for Severe Asthma
The Medical Letter on Drugs and Therapeutics • February 21, 2022; (Issue 1644)
Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen),
a subcutaneously administered thymic stromal
lymphopoietin (TSLP) blocker, has been approved
by the FDA for add-on maintenance treatment of
severe asthma...
Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen),
a subcutaneously administered thymic stromal
lymphopoietin (TSLP) blocker, has been approved
by the FDA for add-on maintenance treatment of
severe asthma in patients ≥12 years old. It is the first
TSLP blocker to become available in the US and the
first biologic drug to be approved for treatment
of severe asthma without phenotypic or biomarker
limitations.
Remimazolam (Byfavo) for Short-Term Procedural Sedation
The Medical Letter on Drugs and Therapeutics • February 21, 2022; (Issue 1644)
The FDA has approved remimazolam (Byfavo – Acacia
Pharma), an ultra-short-acting IV benzodiazepine,
for induction and maintenance of sedation in adults
undergoing procedures of up to 30 minutes'...
The FDA has approved remimazolam (Byfavo – Acacia
Pharma), an ultra-short-acting IV benzodiazepine,
for induction and maintenance of sedation in adults
undergoing procedures of up to 30 minutes' duration.
Odevixibat (Bylvay) for Progressive Familial Intrahepatic Cholestasis-Associated Pruritus
The Medical Letter on Drugs and Therapeutics • February 21, 2022; (Issue 1644)
Odevixibat (Bylvay – Albireo), an oral ileal bile acid
transporter (IBAT) inhibitor, has been approved by the
FDA for treatment of pruritus in patients ≥3 months
old with progressive familial...
Odevixibat (Bylvay – Albireo), an oral ileal bile acid
transporter (IBAT) inhibitor, has been approved by the
FDA for treatment of pruritus in patients ≥3 months
old with progressive familial intrahepatic cholestasis
(PFIC). It is the first drug to be approved in the US for
this indication.
Cabotegravir (Apretude) for HIV-1 Pre-Exposure Prophylaxis
The Medical Letter on Drugs and Therapeutics • February 21, 2022; (Issue 1644)
The FDA has approved Apretude (ViiV Healthcare),
an IM extended-release (ER) formulation of the integrase
strand transfer inhibitor (INSTI) cabotegravir,
for use every 2 months to prevent sexually...
The FDA has approved Apretude (ViiV Healthcare),
an IM extended-release (ER) formulation of the integrase
strand transfer inhibitor (INSTI) cabotegravir,
for use every 2 months to prevent sexually acquired
HIV-1 infection in at-risk adolescents and adults.
Apretude is the first ER formulation to be FDA-approved
for pre-exposure prophylaxis (PrEP) of
HIV-1 infection.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • February 21, 2022; (Issue 1644)
The IV antiviral drug remdesivir (Veklury – Gilead)
has been available for treatment of COVID-19 in
hospitalized patients since 2020. Now, the FDA has
approved remdesivir for treatment of mild to...
The IV antiviral drug remdesivir (Veklury – Gilead)
has been available for treatment of COVID-19 in
hospitalized patients since 2020. Now, the FDA has
approved remdesivir for treatment of mild to moderate
COVID-19 in outpatients ≥12 years old who weigh
≥40 kg and are at high risk for progression to severe
disease, including hospitalization or death; they
also issued an Emergency Use Authorization (EUA)
allowing its use in any other high-risk outpatient who
weighs ≥3.5 kg.
Booster Doses of COVID-19 Vaccines
The Medical Letter on Drugs and Therapeutics • November 29, 2021; (Issue 1638)
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) and the adenovirus-based...
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) and the adenovirus-based vaccine
manufactured by Johnson & Johnson/Janssen to
include administration of a booster dose in select
populations after primary immunization with either the
same COVID-19 vaccine or a different one.
Two New Pneumococcal Vaccines - Prevnar 20 and Vaxneuvance
The Medical Letter on Drugs and Therapeutics • November 29, 2021; (Issue 1638)
The FDA has licensed two new pneumococcal
conjugate vaccines (PCVs) for prevention of invasive
pneumococcal disease in adults: Prevnar 20 (PCV20;
Pfizer), which contains antigens from 20 serotypes...
The FDA has licensed two new pneumococcal
conjugate vaccines (PCVs) for prevention of invasive
pneumococcal disease in adults: Prevnar 20 (PCV20;
Pfizer), which contains antigens from 20 serotypes of
pneumococcus, and Vaxneuvance (PCV15; Merck),
which contains antigens from 15 serotypes. Two
other pneumococcal vaccines are available in the
US: Prevnar 13 (PCV13; Pfizer), a 13-valent conjugate
vaccine licensed for use in persons ≥6 weeks old,
and Pneumovax 23 (PPSV23; Merck), a 23-valent
pneumococcal polysaccharide vaccine licensed for
use in persons ≥2 years old.
Olanzapine/Samidorphan (Lybalvi) for Schizophrenia and Bipolar Disorder
The Medical Letter on Drugs and Therapeutics • November 29, 2021; (Issue 1638)
The FDA has approved Lybalvi (Alkermes), a fixed-dose
combination of the second-generation
antipsychotic olanzapine (Zyprexa, and generics) and
samidorphan, a new opioid antagonist, for treatment
of adults...
The FDA has approved Lybalvi (Alkermes), a fixed-dose
combination of the second-generation
antipsychotic olanzapine (Zyprexa, and generics) and
samidorphan, a new opioid antagonist, for treatment
of adults with schizophrenia or with manic or mixed
episodes of bipolar I disorder. The addition of
samidorphan is intended to mitigate the weight gain
that occurs with olanzapine. This is the first FDA
approval for samidorphan.
In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Children 5-11 Years Old
The Medical Letter on Drugs and Therapeutics • November 29, 2021; (Issue 1638)
The FDA has issued an Emergency Use Authorization
(EUA) for a lower-strength (10 mcg/0.2 mL) formulation
of the mRNA-based COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) for use
in children...
The FDA has issued an Emergency Use Authorization
(EUA) for a lower-strength (10 mcg/0.2 mL) formulation
of the mRNA-based COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) for use
in children 5-11 years old. The original formulation
of (Comirnaty) (30 mcg/0.3 mL) is FDA-licensed for
use in persons ≥16 years old and available under an
EUA for use in adolescents 12-15 years old.
In Brief: Dapagliflozin (Farxiga) for Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • July 26, 2021; (Issue 1629)
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
dapagliflozin (Farxiga – AstraZeneca) has been
approved by the FDA for treatment of adults with
chronic kidney disease (CKD) at risk of...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
dapagliflozin (Farxiga – AstraZeneca) has been
approved by the FDA for treatment of adults with
chronic kidney disease (CKD) at risk of progression
(not defined in the label). Dapagliflozin is the first
SGLT2 inhibitor to be approved in the US for treatment
of CKD.
Sunscreens
The Medical Letter on Drugs and Therapeutics • July 26, 2021; (Issue 1629)
Excessive exposure to ultraviolet (UV) radiation
is associated with sunburn, photoaging, and skin
cancer. Sunscreens are widely used to reduce these
risks, but questions remain about their effectiveness
and...
Excessive exposure to ultraviolet (UV) radiation
is associated with sunburn, photoaging, and skin
cancer. Sunscreens are widely used to reduce these
risks, but questions remain about their effectiveness
and safety. The FDA has issued a proposed rule that
would require manufacturers to perform additional
safety studies for some sunscreen active ingredients
and would mandate better UVA protection in
sunscreen products. Some sunscreen products
containing FDA-approved active ingredients are
listed in Table 2.
Addendum: Aducanumab (Aduhelm) for Alzheimer's Disease
The Medical Letter on Drugs and Therapeutics • July 26, 2021; (Issue 1629)
In June 2021, the FDA approved the IV amyloid beta-directed
monoclonal antibody aducanumab (Aduhelm) for treatment
of Alzheimer’s disease. The approval did not restrict use of
the drug to patients with...
In June 2021, the FDA approved the IV amyloid beta-directed
monoclonal antibody aducanumab (Aduhelm) for treatment
of Alzheimer’s disease. The approval did not restrict use of
the drug to patients with mild cognitive impairment or mild
dementia, which was the population enrolled in the clinical
trials. Now, Biogen, with the permission of the FDA, has made
an addition to the labeling of the drug that says: Treatment with
Aduhelm should be initiated in patients with mild cognitive
impairment or mild dementia stage of disease, the population
in which treatment was initiated in clinical trials. There are no
safety or effectiveness data on initiating treatment at earlier or
later stages of the disease than were studied.
In Brief: Johnson & Johnson COVID-19 Vaccine Suspended (online only)
The Medical Letter on Drugs and Therapeutics • May 3, 2021; (Issue 1623)
On April 13, 2021, the FDA and CDC advised suspending
use of the Johnson & Johnson adenovirus-based
COVID-19 vaccine while the agencies investigate 6
cases of cerebral venous sinus thrombosis (CVST)...
On April 13, 2021, the FDA and CDC advised suspending
use of the Johnson & Johnson adenovirus-based
COVID-19 vaccine while the agencies investigate 6
cases of cerebral venous sinus thrombosis (CVST) and
thrombocytopenia that occurred following administration
of the vaccine. In an April 14 emergency meeting,
the Advisory Committee on Immunization Practices
(ACIP) recommended continuing the suspension until
more data become available. About 7 million people in
the US have received the Johnson & Johnson vaccine.