The Food and Drug Administration (FDA) has withdrawn emergency use authorization for the monoclonal antibody bamlanivimab for use only as a treatment against COVID-19 due to the resistance of variants to the therapy.
The federal agency declared its cancellation of COVID-19 therapy with only bamlanivimab hours after the company Eli Lilly asked the FDA to revoke its emergency license because the variants resistant to the treatment are more common.
As the number of resistant infections increased, the agency concluded that the benefits of treating COVID-19 with bamlanivimab alone “no longer outweigh the known and potential risks of its authorized use.”
The FDA cited data that as of mid-March, about 20 percent of variants in the US are expected to be resistant to bamlanivimab, compared to 5 percent in January.
But the FDA still grants bamlanivimab and another monoclonal antibody, etesevimab, to use together to treat COVID-19 under an emergency use license. In a March study Eli Lilly determined that the combination of monoclonal antibodies – lab-made 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 approved for emergency use remain appropriate treatment choices when used in accordance with authorized labeling and can help keep high-risk patients with COVID-19 out of the hospital,” Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, it said in a release.
“We urge the American public to seek these therapies when needed, while continuing to use the best available data to provide patients with safe and effective treatments during this pandemic,” added Cavazzoni.
The emergency use permission for COVID-19 treatment with bamlanivimab alone, issued in November, was the first monoclonal antibody approved for the treatment of mild to moderate cases of COVID-19. Originally, it could only be used for mild to moderate COVID-19 adult patients and 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 variants affect the treatments allowed for emergency use.
Eli Lilly called on the FDA to end the emergency permit for COVID-19 only treatment with bamlanivimab alone “because of the changing US variation landscape and the full availability of bamlanivimab and etesevimab together.” The company noted that the request for authorization revocation was “not due to new security concerns.”
The company reported that more than 400,000 patients were treated with bamlanivimab, and said it may have prevented more than 20,000 hospitalizations and at least 10,000 deaths in the US.
“With the growing prevalence of variants in the US that may not completely neutralize bamlanivimab alone, and with an adequate supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing agents. antibodies together, ”Eli Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories Daniel Skovronsky said in the release.
Eli Lilly’s request came after the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response stated in March that the US was no longer using bamlanivimab alone. to treat COVID-19.