FDA Rescinds Emergency Use Authorization for Solo Use of Investigational COVID-19 Drug

April 16, 2021 – The U.S. FDA has revoked emergency use authorization (EUA) for bamlanivimab, an investigational drug manufactured by Eli Lilly, for use as a monotherapy to treat mild-to-moderate COVID- 19 in certain adults and pediatric patients. Eli Lilly requested the change due to increasing prevalence of SARS-CoV-2 variants resistant to the drug when it is used alone.

Like other coronaviruses, the SARS-CoV-2 virus that causes COVID-19 mutates over time. This creates new variants that may develop resistance to existing treatments. Based on the current totality of scientific evidence, the FDA determined that the known and potential benefits of bamlanivimab administered alone no longer outweigh the known and potential risks for its authorized use.

Bamlanivimab still holds EUA for use in combination with Eli Lilly’s etesevimab to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40kg) who have tested positive for SARS-CoV-2 and are at high risk of progressing to severe COVID-19 and/or hospitalization. Eli Lilly has modified its contracts with the U.S. government to provide an adequate supply of etesevimab for use in combination with bamlanivimab.

Both Eli Lilly and the FDA have posted announcements regarding the change to their websites.