Press Release 23 April 2021
COVID-19 Treatment Update
COVID-19 Treatment Update: FDA Revokes Emergency Use Authorization for Bamlanivimab
On November 9 2020, Bamlanivimab, administered alone, was approved for emergency use for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. The goal of the use of Bamlanivimab early on was to prevent patient progression to severe disease and hospitalization.
Based on recent data and the emergence of various new variants of SARS-CoV‑2 (the virus that causes Covid-19), it was determined that treatments with Bamlanivimab alone resulted in increased risk of treatment failures.
The FDA has determined that the known and potential benefits of Bamlanivimab, when given alone, no longer outweigh the known and potential risks for its use. Therefore, the agency revoked the Emergency Use Authorization on April 16, 2021.
While the FDA is revoking this Emergency Use Authorization EUA, alternative monoclonal antibody therapies are available under EUA. These include REGEN-COV (Casirivimab and Imdevimab), currently available at Ivinson Memorial Hospital and Bamlanivimab and Etesevimab, administered together.
The FDA believes that these monoclonal antibody therapies remain appropriate to treat patients with COVID-19 based on information available at this time.
For more information, visit the FDA website.