Lilly Asks FDA to Revoke its EUA for Bamlanivimab Alone

Eli Lilly has requested the Food and Drug Administration rescind its Emergency Use Authorization for its COVID-19 therapy, Bamlanivimab. The company has made the request as part of its plan to use Bamlanivimab and etesevimab as a combination therapy for treatment of the virus.

This follows the modification of contracts with the United States government to ensure adequate supply of etesevimab to be used together with bamlanivimab. In addition, the company said with the emerging variants, the standalone therapy might not be as efficacious.

"Lilly moved quickly to make bamlanivimab alone available as a potentially lifesaving medicine at a time when Americans were hardest hit by COVID-19," said Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories. "With the growing prevalence of variants in the US that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together."

Over 400,000 American patients have been treated with bamlanivimab, which according to Lilly, potentially prevented more than 20,000 hospitalizations and at least 10,000 deaths during the worst of the pandemic in the US.

Lilly is not requesting the EUA withdrawal its therapy alone in any other jurisdiction. However, it did say the use of bamlanivimab with etesevimab, where authorized and available, is preferred.

Lilly, in collaboration with Amgen—the manufacturer of etesevimab—expects to manufacture sufficient supply of the therapies to meet global demand.