HHS extends shelf life of Eli Lilly's COVID-19 antibody drug

HHS has extended the shelf life of Eli Lilly's COVID-19 antibody cocktail drug for six more months. 

The drug, a combination of monoclonal antibodies etesevimab and bamlanivimab, can now be refrigerated for 18 months instead of 12, HHS said Oct. 22. The department said it granted the extension after thoroughly reviewing data submitted by Eli Lilly, and that it applies to all unopened vials of the drug. 

The antibody cocktail was granted emergency use authorization in February. In September, the FDA revised the drug's authorization, allowing it to be used as a post-exposure prophylaxis for COVID-19 for people exposed to the virus who are at high risk for severe disease. It's administered via a single intravenous infusion. 

Phase 3 trial data showed that administering etesevimab and bamlanivimab together reduced the risk of COVID-19 hospitalization and death by 70 percent. 

Eli Lilly's cocktail is the second to be granted emergency use authorization for post-exposure COVID-19 prophylaxis. The FDA revised the emergency use authorization for Regeneron's COVID-19 antibody cocktail, a combination of casirivimab and imdevimab, in July.

 

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