FDA Authorizes, HHS Purchases New COVID-19 Monoclonal Antibody Therapeutic

Today, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the Omicron variant. The new monoclonal antibody bebtelovimab has been authorized for treatment of mild to moderate COVID-19 in adults and pediatric patients with a positive COVID-19 test and who are at high risk for progression of severe COVID-19. Bebtelovimab, manufactured by Eli Lilly and Company, is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra announced this week that the federal government has purchased 600,000 treatment courses of the new monoclonal antibody treatment that is effective against the COVID-19 Omicron variant. HHS has indicated the therapeutic will be provided to states free of charge.

Under the purchase agreement announced this week, HHS would receive approximately 300,000 treatment courses in February and approximately 300,000 treatment courses in March. The contract also includes a future option for 500,000 more doses.

Additional information from the FDA is available here. Additional information from HHS is available here.