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FDA Halts Use of Regeneron, Lilly COVID Antibody Therapies

Says the therapies are less able to target Omicron because of its mutations.

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By: Kristin Brooks

Managing Editor, Contract Pharma

The FDA halted the use of Regeneron’s REGEN-COV and Eli Lilly’s Bamlanivimab and etesevimab COVID-19 antibody drugs.
 
Emergency authorization for the monoclonal antibody treatments was revoked by the U.S. FDA citing the drugs were less able to target the Omicron variant because of mutations.  
 
Last month, the U.S. government paused the distribution of Regeneron and Lilly’s treatments until pending new data on their efficacy against Omicron.
 
According to the FDA, reauthorization of the treatments would depend on studies showing efficacy against potential future variants.
 
The therapies, which were purchased by the U.S. government and have already been administered to millions of people with COVID, are lab-made versions of virus-blocking antibodies.
 
The treatments are meant to prevent severe disease and death by supplying concentrated doses of one or two antibodies early on in infection. 

Related News:
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Lilly’s Antibody Treatment Gets EUA for Post-Exposure COVID Prevention

U.S. Govt. Purchases Additional Doses of Lilly’s Antibody Therapies for COVID

Regeneron’s COVID-19 Antibody Cocktail Gets EUA

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