(RTTNews) - Eli Lilly and Company (LLY) has requested the FDA revoke the Emergency Use Authorization for bamlanivimab 700 mg alone. This is the final step in the company's transition to only supply bamlanivimab and etesevimab for administration together in the U.S. for the treatment of COVID-19. The company noted that the request is not due to any new safety concern.
Lilly's bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the FDA as a treatment for mild to moderate COVID-19. Lilly said all sites in the U.S. now have access to obtain doses of etesevimab for administration with bamlanivimab — which together neutralize more of the emerging COVID-19 variants in the U.S. than bamlanivimab alone.
Lilly, in collaboration with Amgen, plans to manufacture sufficient supply of bamlanivimab and etesevimab together. Lilly will submit only bamlanivimab administered with etesevimab together for authorization globally with a full transition expected by June 2021.
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