Lilly requests FDA revoke EUA for COVID antibody

April 16, 2021

Eli Lilly and Co. has requested that the U.S. FDA cancel the emergency use authorization granted to its COVID-19 antibody, bamlanivimab, for use alone, in favor of the drug being used in combination with another therapy.

According to Lilly, the request was made in response to the new variants in the country that could be resistant to bamlanivimab when used alone. Instead, the drugmaker says that bamlanivimab, used in combination with the drug, etesevimab will neutralize more emerging COVID-19 variants.

"In the U.S., bamlanivimab alone should no longer be administered. However, sites of care should not dispose of bamlanivimab supply; instead, they should order etesevimab to pair with it," said Lilly.

Back in November, bamlanivimab was the first neutralizing monoclonal antibody to receive EUA from the FDA as a treatment for mild to moderate COVID-19. This past February, the FDA issued EUA to Eli Lilly for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19.

Lilly, in collaboration with Amgen, expects to manufacture sufficient supply of bamlanivimab and etesevimab together to meet global supply needs.

Read the Eli Lilly press release