FDA Revokes Emergency Use Authorization for Eli Lilly's Bamlanivimab Due to Rising Viral Resistance

Editor: Wu Bin

As the novel coronavirus continues to mutate, U.S. pharmaceutical giant Eli Lilly was unexpectedly caught in the crossfire when the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization for its COVID-19 antibody drug, bamlanivimab, on Friday.

In its statement, the FDA explained that due to the increasing prevalence of SARS-CoV-2 variants resistant to bamlanivimab, using this drug alone to treat patients with COVID-19 carries an “increasingly high risk of treatment failure.” The benefits of the drug no longer outweigh its risks, and it no longer meets the criteria for Emergency Use Authorization.

On November 9 last year, Eli Lilly’s COVID-19 antibody drug bamlanivimab received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), becoming the first investigational COVID-19 antibody therapy to be granted such authorization. On January 21 this year, Eli Lilly and Company announced that its antibody drug bamlanivimab had demonstrated efficacy in reducing the risk of symptomatic infection among elderly residents and staff in long-term care facilities during clinical trials.

Notably, prior to the FDA’s announcement on Friday revoking the emergency use authorization for Eli Lilly’s COVID-19 antibody drug, Eli Lilly had already acknowledged that the efficacy of bamlanivimab monotherapy had declined due to certain variant strains circulating in the United States. Going forward, Eli Lilly will focus on promoting the cocktail therapy combining bamlanivimab with its second antibody drug, etesevimab.

Although the emergency use authorization for the COVID-19 monoclonal antibody bamlanivimab has been revoked, the FDA emphasizes that Regeneron’s REGEN-COV antibody cocktail and Eli Lilly’s bamlanivimab and etesevimab combination therapy remain available.