The Medical Letter on Drugs and Therapeutics
FROM
ISSUE 1621
ISSUE 1621
April 5, 2021
Issue 1621
- An EUA for Bamlanivimab and Etesevimab for COVID-19
- Oriahnn for Fibroid-Associated Heavy Menstrual Bleeding
- Semaglutide (Ozempic) for Weight Loss
- Low-Dose Colchicine for Coronary Artery Disease
- In Brief: Hypertension with Erenumab (Aimovig)
- Ripretinib (Qinlock) for GIST (online only)
- COVID-19 Vaccine Comparison Chart (online only)
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An EUA for Bamlanivimab and Etesevimab for COVID-19
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 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.
... more
- FDA News Release. Coronavirus (COVID-19) update: FDA authorizes monoclonal antibodies for treatment of COVID-19. February 9, 2021. Available at: http://bit.ly/3d8grHG. Accessed Accessed March 17 2021.
- An EUA for bamlanivimab – a monoclonal antibody for COVID-19. Med Lett Drugs Ther 2020; 62:185.
- An EUA for casirivimab and imdevimab for COVID-19. Med Lett Drugs Ther 2020; 62:201.
- RL Gottlieb et al. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA 2021; 325:632.
- FDA. Fact sheet for health care providers. Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. Available at: https://bit.ly/3qfS6DN. Accessed March 17, 2021.
- Lilly News Release. Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in phase 3 trial for early COVID-19. March 10, 2021. Available at: http://bit.ly/2PRZmZ7. Accessed March 17, 2021.
- Lilly News Release. Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19. February 9, 2021. Available at: http://bit.ly/3jGYIbM. Accessed March 17, 2021.

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