FDA Revokes Authorization Of Eli Lilly’s COVID-19 Antibody

The US FDA has withdrawn the authorization of bebtelovimab, Eli Lilly and CO’s COVID-19 antibody treatment. The drug regulator has explained that it does not expect the monoclonal antibody to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron. 

Following the FDA’s verdict, Eli Lilly has paused the commercial distribution of bebtelovimab, while the US government has also halted its scheme to distribute the drug to financially vulnerable patients. Previously, the company agreed to supply an additional 60,000 doses to the US government for approximately $110 million. 

Bebtelovimab was discovered by Abcellera and marketed by Eli Lilly under an agreement made in March 2020. The FDA authorized the antibody in February 2022. 

According to Eli Lilly’s financial report for the third quarter of 2022, sales of its COVID-19 antibodies, including bamlanivimab, etesevimab, and bebtelovimab reached $386.6 million, a 78% increase from last year. 

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Rise Of The Subvariants

The two strains have become the dominant strains in the US after seeing a rise in prevalence in the last two months, surpassing the BA.5 subvariant which had driven cases earlier this year. The US Centers for Disease Control and Prevention (CDC) recently estimated that the subvariants account for over half of the COVID-19 cases in the country. 

While there is no evidence that the subvariants are linked to increased severity compared to the circulating Omicron variants BA.4 and BA.5, the European Center for Disease Prevention and Control has warned that they may evade immune protection, citing laboratory studies in Asia.

Bebtelovimab’s exit leaves Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease. 

Another monoclonal antibody, AstraZeneca’s Evusheld retains its emergency use authorization for use in the immunocompromised. However, the FDA in October updated information on Evusheld to warn of an increased risk of developing COVID-19 when exposed to variants of the virus that are not neutralized by the drug. 

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Joy Lin

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