FDA denies EUA for monoclonal antibody treatment bamlanivimab to treat patients with COVID

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• Source: U.S. Food and Drug Administration


• Date: 18 Apr,2021

Now, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody treatment bamlanivimab, when administered alone, to be utilized for treating mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone leading to the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and possible risks for its authorized use. Therefore, the agency decided that the criteria for issuance of an authorization are no longer met and has revoked the EUA.

On Nov. 9, 2020, based on the totality of scientific evidence available at the time, the FDA issued an EUA into Eli Lilly and Co. authorizing the emergency use of bamlanivimab alone for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years old and older weighing at least 40 kg) with favorable outcomes of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to acute COVID-19 and/or hospitalization. Importantly, though the FDA is currently revoking this EUA, alternative monoclonal antibody therapies remain available under EUA, such as REGEN-COV (casirivimab and imdevimab, administered collectively ), and bamlanivimab and etesevimab, administered collectively, for the same applications as previously authorized for bamlanivimab alone.

While the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital. We urge the American public to seek out these therapies when needed while we continue to use the best data available to provide patients with safe and effective treatments during this pandemic.”

Patrizia Cavazzoni, M.D., Director, FDA’s Center for Drug Evaluation and Research

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.

The FDA has a responsibility to regularly review the appropriateness of an EUA, and therefore, the agency will review emerging information connected to the emergency applications for the licensed products. Recent data in the U.S. Centers for Disease Control and Prevention’s (CDC) national genomic surveillance software show an increased frequency of SARS-CoV-2 variants that are predicted to be immune to bamlanivimab administered independently. As of mid-March 2021, approximately 20 percent of viruses sequenced from the U.S. were reported as variations expected to be resistant to bamlanivimab alone, increasing from approximately 5% in mid-January 2021.

Furthermore, there are currently no testing technologies available that enable healthcare providers to check individual patients for SARS-CoV-2 viral variations prior to start of therapy with monoclonal antibodies. Therefore, empiric treatment with monoclonal antibody therapies that are expected to work broadly against all variants throughout the nation should be used to reduce the chances of treatment failure.

The FDA will continue working closely with other federal governmental agencies, including the CDC and the National Institutes of Health, on the surveillance of variants that may affect the monoclonal antibody therapies authorized for emergency use.