Lilly asks FDA to revoke authorization for lone use of COVID-19 drug bamlanivimab

Eli Lilly and Co said on Friday it had requested the U.S. health regulator to revoke the emergency use authorization granted to its COVID-19 antibody, bamlanivimab, as it focuses on supplying the drug in combination with another therapy. The request made to the U.S. Food and Drug Administration is not due to any new safety issues, the drugmaker said in a statement.

Eli Lilly and Co said on Friday it had requested the U.S. health regulator to revoke the emergency use authorization granted to its COVID-19 antibody, bamlanivimab, as it focuses on supplying the drug in combination with another therapy.

The request made to the U.S. Food and Drug Administration is not due to any new safety issues, the drugmaker said in a statement. The latest decision was made in response to the new variants of the coronavirus emerging in the country which are resistant to bamlanivimab when used alone. The U.S. government had stopped the distribution of the therapy last month.

Lilly earlier this week said it had revised its pact with the U.S. government to enable the supply of another drug called etesevimab to complement doses of bamlanivimab that the U.S. government had already purchased. Etesevimab and bamlanivimab together neutralize more of the emerging COVID-19 variants in the U.S. than bamlanivimab alone, including the rapidly growing B.1.427/B.1.429 California strain, Lilly said on Friday.

 

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