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Lilly Asks FDA to Revoke Covid-19 Therapy Clearance

SARS-CoV-2 and cell

Scanning electron microscope image shows SARS-CoV-2 viruses emerging from the surface of cells cultured in the lab. (NIAID, NIH)

16 Apr. 2021. Drug maker Eli Lilly and Co. asked the Food and Drug Administration to revoke its authorization for bamlanivimab alone to treat for Covid-19 infections. The pharmaceutical maker says its synthetic monoclonal antibody bamlanivimab by itself does not neutralize emerging SARS-CoV-2 variants as well as bamlanivimab combined with etesevimab, another of its antibodies.

Bamlanivimab was authorized by FDA as a treatment for infections from the original strain of SARS-CoV-2 causing mild to moderate symptoms. As reported by Science & Enterprise in February, FDA also authorized bamlanivimab combined with etesevimab to treat non-hospitalized people with Covid-19 infections showing mild to moderate symptoms, but considered at high risk for severe symptoms of the disease.

Lilly says bamlanivimab with etesevimab neutralizes more of the newer strains of the SARS-CoV-2 virus responsible for Covid-19 infections, including the B.1.427/B.1.429 strain that now accounts for half of the virus in California and is spreading to other states. The company developed the dual-antibody cocktail for the eventual emergence of viral mutations that resist one of the antibodies working alone.

The company says it expected new variants to arise, and the request to revoke the authorization will encourage transition to the bamlanivimab/etesevimab combination. “With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize,” says Lilly’s chief scientist Daniel Skovronsky in a company statement, “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 is collaborating with fellow drug maker Amgen to manufacture bamlanivimab and etesevimab to meet global needs. The company says it plans to submit the dual-antibody cocktail to health authorities worldwide for regulatory review, and expects a full transition to the two-drug combination by June of this year.

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