Matching articles for "imdevimab"

COVID-19 Updates

   
The Medical Letter on Drugs and Therapeutics • January 24, 2022;  (Issue 1642)
On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody...
On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.
Med Lett Drugs Ther. 2022 Jan 24;64(1642):16 | Show Full IntroductionHide Full Introduction

Tixagevimab and Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis of COVID-19

   
The Medical Letter on Drugs and Therapeutics • January 10, 2022;  (Issue 1641)
The FDA has issued an Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to be administered concomitantly by...
The FDA has issued an Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to be administered concomitantly by IM injection for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of severe allergy that prevents their vaccination against COVID-19 or moderate or severe immune compromise (see Table 1). They are the first drugs to be authorized by the FDA for this indication. Two other pairs of antibodies, bamlanivimab plus etesevimab (Lilly) and casirivimab plus imdevimab (REGEN-COV), are authorized for post-exposure prophylaxis of COVID-19.
Med Lett Drugs Ther. 2022 Jan 10;64(1641):1-2 | Show Full IntroductionHide Full Introduction

Bamlanivimab and Etesevimab for Post-Exposure Prophylaxis of COVID-19

   
The Medical Letter on Drugs and Therapeutics • October 18, 2021;  (Issue 1635)
In February 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibodies bamlanivimab and etesevimab (Lilly) for use together to treat mild to moderate COVID-19 in...
In February 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibodies bamlanivimab and etesevimab (Lilly) for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response to full vaccination and have been in close contact with a SARS-CoV-2-infected individual or are likely to be exposed to SARS-CoV-2 in the setting of an institutional outbreak (see Table 1). Bamlanivimab plus etesevimab is the second monoclonal antibody combination to receive an EUA for post-exposure prophylaxis of COVID-19; casirivimab plus imdevimab (REGEN-COV) was authorized earlier.
Med Lett Drugs Ther. 2021 Oct 18;63(1635):163-4 | Show Full IntroductionHide Full Introduction

Casirivimab and Imdevimab (REGEN-COV) for Post-Exposure Prophylaxis of COVID-19

   
The Medical Letter on Drugs and Therapeutics • August 23, 2021;  (Issue 1631)
The investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV – Regeneron) have been available in the US under an Emergency Use Authorization (EUA) since late 2020 for use together to...
The investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV – Regeneron) have been available in the US under an Emergency Use Authorization (EUA) since late 2020 for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons, if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response to full vaccination and have been in close contact with a SARS-CoV-2-infected individual or are likely to be exposed to SARS-CoV-2 in the setting of an institutional outbreak (see Table 1). Casirivimab and imdevimab are the first drugs to receive an EUA for post-exposure prophylaxis of COVID-19.
Med Lett Drugs Ther. 2021 Aug 23;63(1631):130-1 | Show Full IntroductionHide Full Introduction

An EUA for Sotrovimab for Treatment of COVID-19

   
The Medical Letter on Drugs and Therapeutics • June 28, 2021;  (Issue 1627)
The investigational monoclonal antibody sotrovimab (VIR-7831; GSK/Vir Biotechnology) has been granted an FDA Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in patients ≥12...
The investigational monoclonal antibody sotrovimab (VIR-7831; GSK/Vir Biotechnology) has been granted an FDA Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death.1 Two other monoclonal antibody regimens are authorized for the same indication: casirivimab (REGN10933) and imdevimab (REGN10987) administered together, and bamlanivimab (LY-CoV555) and etesevimab (LYCoV016) administered together. The FDA revoked its EUA for bamlanivimab alone in April 2021 because an increasing percentage of COVID-19 cases in the US are being caused by SARS-CoV-2 variants that are resistant to monotherapy with the drug.
Med Lett Drugs Ther. 2021 Jun 28;63(1627):97-8 | Show Full IntroductionHide Full Introduction

An EUA for Bamlanivimab and Etesevimab for COVID-19

   
The Medical Letter on Drugs and Therapeutics • April 5, 2021;  (Issue 1621)
The FDA has issued an Emergency Use Authorization (EUA) for Lilly's investigational monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to be administered together for treatment...
The FDA has issued an Emergency Use Authorization (EUA) for Lilly's investigational monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to be administered together for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease and/or hospitalization (see Table 1). Bamlanivimab received an EUA for use as monotherapy in such patients in November 2020. Regeneron's investigational monoclonal antibodies casirivimab (REGN10933) and imdevimab (REGN10987) are also authorized for use together for the same indication.
Med Lett Drugs Ther. 2021 Apr 5;63(1621):49-50 | Show Full IntroductionHide Full Introduction

An EUA for Casirivimab and Imdevimab for COVID-19

   
The Medical Letter on Drugs and Therapeutics • December 28, 2020;  (Issue 1614)
The FDA has issued an Emergency Use Authorization (EUA) for Regeneron's investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV) to be administered together by IV infusion or SC injection...
The FDA has issued an Emergency Use Authorization (EUA) for Regeneron's investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV) to be administered together by IV infusion or SC injection for treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years old and weigh ≥40 kg) who are at high risk of progressing to severe COVID-19 and/or hospitalization.
Med Lett Drugs Ther. 2020 Dec 28;62(1614):201-2 | Show Full IntroductionHide Full Introduction