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FDA Pulls Authorization for Lilly’s COVID Drug Bebtelovimab

FDA says the drug is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

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By: Kristin Brooks

Managing Editor, Contract Pharma

The U.S. FDA has pulled authorization for Eli Lilly and Co’s COVID-19 drug bebtelovimab, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.
 
In February, the FDA issued Emergency Use Authorization for bebtelovimab, a monoclonal antibody treatment that demonstrated neutralization against the Omicron variant.
 
The data supporting this EUA were primarily based on analyses demonstrating that bebtelovimab retains full neutralizing activity against Omicron. Additionally, pseudovirus testing with bebtelovimab demonstrated that it retains neutralization against all other known variants of interest and concern, including BA.2.

Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice.
 
Remaining approved treatments for COVID inlcude Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio and Gilead’s Veklury.

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