FDA Revokes Regeneron’s Approval for Covid Antibody Treatments, Eli Lilly

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The U.S. Food and Drug Administration on Monday revoked its approval for treatments using Covid-19 monoclonal antibodies made by Regeneron Pharmaceuticals and Eli Lilly after those treatments proved ineffective against the Omicron variant, more than one Month after some hospitals voluntarily decided to stop offering the drugs.

Important facts

Because Regeneron’s REGEN-COV treatment and Eli Lilly’s bamlanivimab and etesevimab treatments are “highly unlikely to be active against the Omicron variant,” which is currently the case 99,5 % In most cases they are from Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, is no longer approved said in an opinion.

The decision, made on the basis of new data, avoids exposing patients to the treatments’ side effects, including potentially serious allergic reactions, Cavazzoni said.

The announcement came less than a month after the FDA’s Dec. 23 decision to temporarily suspend the sale of Regeneron and Eli Lilly treatments due to their ineffectiveness.

Cavazzoni highlighted other therapies, including Pfizer’s Covid-19 antiviral pill Paxlovid, which retain FDA approval and are expected to perform well against Omicron.

Regeneron and Eli Lilly treatments could be re-authorized if a variant they are effective against becomes common again, Cavazzoni said.

key background

Monoclonal antibody treatments can prevent serious illness or hospitalization in high-risk Covid-19 patients by boosting the body’s natural immune response. Although Regeneron’s and Eli Lilly’s treatments worked against earlier variants of the virus, Omicron’s mutation in a spike protein that the treatments targeted all but eliminated their effectiveness. Over a month before the FDA’s announcement Monday, hospitals like NewYork-Presbyterian Hospital had voluntarily stopped offering the treatments. Sotrovimab, a monoclonal antibody treatment made by GlaxoSmithKline and Vir Biotechnology, still appears to be effective against Omicron, the Centers for Disease Control and Prevention said. However, hospitals in New York, Maine, Texas and other states are struggling to maintain supplies of sotrovimab. In December 2021, the White House announced plans to ship approximately 300,000 doses of sotrovimab to state and territory health officials in January. January 11 GlaxoSmithKline announced that the federal government had agreed to buy an additional 600,000 cans.

Further reading

“FDA Revokes Approval for Covid Antibody Treatments” (financial times)

“US suspends distribution of monoclonal antibody treatments proven ineffective against Omicron” (Forbes)


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