FDA Authorizes Monoclonal Antibodies for Mild to Moderate COVID-19

The FDA has issued an emergency use authorization for the use of bamlanivimab and etesevimab together in treating mild to moderate COVID-19 in patients who are at high risk of developing severe COVID-19.

The treatment has been approved for use in adults, pediatric patients over 12 years of age that weigh at least 40 kilograms, older adults aged 65 years or older, and those with some chronic medical conditions. These monoclonal antibodies are to be delivered together through a one-time intravenous infusion with a dosage of 700 milligrams of bamlanivimab and 1400 milligrams of etesevimab. Bamlanivimab was previously authorized for emergency use by the FDA for the treatment of mild to moderate COVID-19.

The emergency use authorization follows a randomized, double-blind, placebo-controlled clinical trial. The trial included 1035 non-hospitalized adults, of which 517 participants received a placebo while 518 participants received a dose of 2800 milligrams bamlanivimab and 2800 milligrams etesevimab. Of those who received the infusion, hospitalization occurred in only 2% (n=11) of patients. This was a 70% reduction from the 7% (n=36) of patients who received placebo and were hospitalized or were part of the 10 total deaths. No deaths occurred in the treatment group.

Side effects of this combination infusion include nausea, dizziness, pruritus, and rash. Additionally, hypersensitivity, anaphylaxis, and infusion-related reactions have been reported for bamlanivimab, both with and without the use of etesevimab.

—Leigh Precopio

Reference:

Coronavirus (COVID-19) update: FDA authorizes monoclonal antibodies for treatment of COVID-19. News release. February 9, 2021. US Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0?utm_medium=email&utm_source=govdelivery