Lilly Seeks to Revoke Emergency Use Authorization
(Provided Photo/Eli Lilly and Co.)
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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowIndianapolis-based Eli Lilly and Co. (NYSE: LLY) is asking the U.S. Food and Drug Administration to revoke the Emergency Use Authorization it received for bamlanivimab as a standalone COVID therapy. Lilly says the drug is more effective when it is used in conjunction with etesevimab, which was developed by California-based Amgen (Nasdaq: AMGN).
Lilly says the request is not due to any safety concerns.
Bamlanivimab was one of the first antibodies to receive emergency use authorization from the FDA as a treatment for mild to moderate COVID-19. The company says it provided a “valuable treatment at a time when cases were at their highest in the U.S.”
But as various strains of COVID evolve, Lilly says the combination is more effective.
“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 Dr. Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories. “With the growing prevalence of variants in the U.S. 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.”
Lilly says bamlanivimab alone should no longer be administered. However, health facilities should not dispose of the therapy, instead, they should order etesevimab to pair with it.
Looking ahead, Lilly says it will submit only bamlanivimab administered with etesevimab together for authorization globally with a full transition expected by June 2021.