FDA Revokes Emergency Use of Solo Bamlanivimab for COVID
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FDA revokes emergency use authorization for bamlanivimab in COVID-19 patients. Agency says SARS-CoV-2 viral variants have increased the risk for treatment failure. Agency determined that the criteria for issuance of authorization are no longer met and has revoked the EUA. The FDA says the monoclonal antibody therapy can no longer be used when administered alone.

On Nov. 9, 2020, based on the totality of scientific evidence available at the time, the FDA issued a EUA to Eli Lilly and Co. authorizing the emergency use of bamlanivimab alone. The FDA is now revoking this EUA. Alternative monoclonal antibody therapies remain available under EUA, including REGEN-COV (casirvimab and imdevimab, administered together) and bam Lanivimb and etesevimab.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. Like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains.

The FDA has a responsibility to regularly review the appropriateness of an EUA. Data show an increased frequency of SARS-CoV-2 variants that are expected to be resistant to bamlanivimab administered alone. As of mid-March 2021, approximately 20% of viruses sequenced in the U.S. were reported as resistant to the drug.

Additionally, there are currently no testing technologies available that enable health care providers to test individual patients for SARS-CoV-2 viral variants prior to the start of treatment with monoclonal antibodies. Therefore, empiric treatment with monoclonal antibody therapies that are expected to work broadly against variants across the nation should be used to reduce the likelihood of treatment failure.

Source:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab
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