The Food and Drug Administration (FDA) terminated its emergency use authorization to use the monoclonal antibody bamlanivimab as a treatment for COVID-19 due to the resistance of the variants to therapy.
The federal agency declared the cancellation of COVID-19 therapy only with bamlanivimab hours after the company Eli Lilly applied to the FDA for the revocation of the emergency authorization because the treatment-resistant variants were they have become more frequent.
With the growing number of resistant infections, the agency concluded that the benefits of treating COVID-19 with bamlanivimab alone “no longer outweigh the known and potential risks for its authorized use.”
The FDA cited data that by mid-March it was expected that approximately 20 percent of variants in the U.S. would be resistant to bamlanivimab, compared to 5 percent in January.
But the FDA still grants bamlanivimab and another monoclonal antibody, etesevimab, which will be used together to treat COVID-19 under an emergency use authorization. In a March study, Eli Lilly determined that the combination of monoclonal antibodies, laboratory-created proteins that copy how the immune system responds to viruses, reduced the risk of hospitalization and death from COVID-19 by 87 percent.
“Other monoclonal antibody therapies authorized for emergency use remain appropriate treatment options when used in accordance with authorized labeling and may help keep patients at high risk of COVID out of the hospital. 19 “said Patrizia Cavazzoni, director of the FDA’s Drug Evaluation Center. and Research said in a statement.
“We urge the American public to seek out these therapies when needed while continuing to use the best data available to provide patients with safe and effective treatments during this pandemic,” Cavazzoni added.
The emergency use authorization for COVID-19 treatment with bamlanivimab alone, granted in November, was the first monoclonal antibody approved to treat mild to moderate COVID-19 cases. Originally, it was allowed to be used alone for mild to moderate adult COVID-19 patients and for some children at high risk for 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 the impact of variants on authorized treatments for emergency use.
Eli Lilly asked the FDA to end the emergency clearance for COVID-19 treatment with bamlanivimab alone “due to the changing landscape variation in the US and the full availability of bamlanivimab and etesevimab together.” The company noted that its application for revocation of the permit “is not due to any new security concerns.”
The company reported that more than 400,000 patients were treated with bamlanivimab, and said it could prevent more than 20,000 hospitalizations and at least 10,000 deaths in the U.S.
“With the growing prevalence of variants in the United States that bamlanivimab alone cannot completely neutralize and with a sufficient supply of etesevimab, we believe this is the right time to complete our planned transition and focus on administration of these two neutralizing antibodies together “. Eli Lilly’s chief scientific director and president of Lilly’s research labs, Daniel Skovronsky, said in the statement.
Eli Lilly’s request came after the Office of the Undersecretary of Preparedness and Response of the Department of Health and Human Services declared in March that the U.S. had stopped using bamlanivimab alone. to treat COVID-19.