FDA grants EUA for COVID-19 monoclonal antibody treatment

Feb. 10, 2021

The U.S. Food and Drug Administratiom (FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19, according to a news release from the agency.

The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. Pediatric patients must be at least 12 years old and weigh 88 pounds or more.

The EUA was issued to Eli Lilly and Co.

In a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared to placebo.

The FDA EUA for Bamlanivimab and etesevimab does not include authorization for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19, the FDA said. Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 who require high flow oxygen or mechanical ventilation.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Bamlanivimab and etesevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.

The data supporting this EUA for bamlanivimab and etesevimab are based on a randomized, double-blind, placebo-controlled clinical trial in 1,035 non-hospitalized adults with mild to moderate COVID-19 symptoms who were at high risk for progressing to severe COVID-19. Of these patients, 518 received a single infusion of bamlanivimab and etesevimab; 517 received placebo. The primary endpoint was COVID-19 related hospitalizations or death by any cause during 29 days of follow-up. Hospitalization or death occurred in 36 (7 percent) patients who received placebo, compared to 11 (2 percent) patients treated with bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams administered together. All 10 deaths (2 percent) deaths occurred in the placebo.

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