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FDA cancels emergency authorization for COVID-19 antibody treatment bamlanivimab



The U.S. Food and Drug Administration (FDA) cancelled the emergency use authorization of its monoclonal antibody bamlanivimab, which was used alone as a treatment against COVID-19 due to the resistance of the variant to the therapy.

After Eli Lilly asked the FDA to revoke the emergency authorization, the federal agency announced the cancellation of COVID-19 treatment that only contained bamlanivimab, because variants resistant to this treatment have become more common.

With the increase in the number of drug-resistant infections, the agency concluded that the benefits of using sambanibizumab alone to treat COVID-1

9 “no longer exceed the known and potential risks of its authorized use.”

The FDA cited data that as of mid-March, approximately 20% of variants in the United States are expected to be resistant to bamlanivimab, compared with 5% in January.

However, the FDA still granted bamlanivimab and another monoclonal antibody etesevimab to treat COVID-19 together under emergency use authorization. In the March study, Eli Lilly has determined that a combination of monoclonal antibodies-proteins created in the laboratory that replicate the immune system’s response to the virus-reduces the risk of hospitalization and death due to COVID-19 by 87%.

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation, said: “Other monoclonal antibody therapies authorized for emergency use under the authorization label are still appropriate treatment options and can help keep high-risk COVID-19 patients out. “And the Research Department said in a press release.

Cavazzoni added: “We urge the American public to look for these therapies when needed, and we will continue to use the best data available to provide safe and effective treatments for patients during the pandemic.”

The emergency use authorization for COVID-19 treatment containing only phenylalanine monoclonal antibody obtained in November is the first batch of monoclonal antibodies approved for the treatment of mild to moderate COVID-19 cases. It initially allowed it to be used alone in adult patients with mild to moderate COVID-19 and some high-risk children with severe coronavirus disease or hospitalization.

The federal agency said it will work with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to monitor how the variant affects treatments authorized for emergency use.

Eli Lilly calls on FDA to terminate emergency authorization Only due to the use of bamlanivimab for COVID-19 treatment, “due to the evolving pattern of variation in the United States and the full supply of bamlanivimab and etesevimab.” The company noted that the request to revoke authorization “is not due to any new security risks.”

The company reports that more than 400,000 patients have been treated with bamlanivimab and said it may prevent more than 20,000 hospitalizations and at least 10,000 deaths in the United States.

“With the popularity of variants in the United States, bamlanivimab alone may not be completely neutralized, and with enough etesevimab, we think now is the right time to complete the planned transition and concentrate on administering these two neutralizing antibodies at the same time. ,” Daniel Skovronsky, Eli Lilly’s chief scientific officer and president of Eli Lilly’s research laboratories, said in a press release.

Eli Lilly’s request came after the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services announced in March that the United States would no longer use bamlanivimab alone. Treat COVID-19.




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