The Food and Drug Administration (FDA) has revoked its emergency use authorization for the monoclonal antibody bamlanivimab to be used alone as a treatment against COVID-19 due to the resistance of the variants to therapy.
The federal agency declared the cancellation of COVID-19 therapy only with bamlanivimab, after Eli Lilly asked the FDA to revoke the emergency authorization because treatment-resistant variants became more common.
As the number of resistant infections increases, the agency concluded that the benefits of COVID-19 treatment with bamlanivimab alone “do not outweigh the known and potential risks to authorized use”.
The FDA cited data that by mid-March, about 20% of US variants were expected to be resistant to bamlanivimab, compared with 5% in January.
But the FDA still grants bamlanivimab and another monoclonal antibody, etesevimab, to be used together to treat COVID-19 under an emergency use authorization. In a March study, Eli Lilly determined 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%.
“Other emergency-approved monoclonal antibody therapies remain appropriate treatment options when used in accordance with authorized labeling and may help keep high-risk patients with COVID-19 out of the hospital,” said Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research said in a statement.
“We urge the American public to seek these therapies when necessary, while continuing to use the best available data to provide patients with safe and effective treatments during this pandemic,” Cavazzoni added.
The emergency use authorization for bamlanivimab-only treatment of COVID-19 in November was the first approved monoclonal antibody to treat mild to moderate COVID-19. It was initially used in adult patients with mild to moderate COVID-19 and in 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 how the variants impact authorized treatments for emergency use.
Eli Lilly asked the FDA to terminate the emergency authorization for COVID-19 treatment with bamlanivimab alone “due to the evolving landscape in the US and the full availability of bamlanivimab and etesevimab together”. The company noted that its application for revocation of the permit was not “due to new safety issues”.
The company reported that more than 400,000 patients were treated with bamlanivimab, saying it could prevent more than 20,000 hospitalizations and at least 10,000 deaths in the United States.
“Given the growing prevalence of US variants that bamlanivimab alone cannot completely and sufficiently neutralize etesevimab, we believe this is the right time to complete the planned transition and focus on co-administering these two neutralizing antibodies.” Eli Lilly’s scientific director and president of Lilly’s research laboratories, Daniel Skovronsky, said in a statement.
Eli Lilly’s request came after the Deputy Office of the Secretary for Preparedness and Response of the Department of Health and Human Services said in March that the United States had stopped using bamlanivimab alone. to treat COVID-19.