The Food and Drug Administration (FDA) has withdrawn its emergency use authorization for the monoclonal antibody bamlanivimab to be used alone as a treatment against COVID-19 due to resistance to treatment.
The federal agency announced that the COVID-19 therapy that treated only bamlanivimab was canceled a few hours after the company Eli Lilly requested the FDA to revoke the emergency consent because the variants that are resistant to the treatment have become more common .
With the growing number of resistant infections, the agency has concluded that the benefits of treating COVID-19 with bamlanivimab alone “do not outweigh the known and potential risks to its permitted use.”
The FDA cited data that is expected to have about 20 percent of variants in the U.S. resistant to bamlanivimab by mid-March, compared to 5 percent in January.
But the FDA is still granting bamlanivimab and another monoclonal antibody, etesevimab, to be used together to treat COVID-19 under an emergency. In a March study, Eli Lilly determined that the combination of monoclonal antibodies – proteins created by the laboratory that copy how the immune system responds to viruses – reduced the risk of hospitalization and death of COVID-19 by 87 percent.
“Other monoclonal antibody therapies that are permitted for emergency use remain appropriate treatment choices when used according to authorized labeling and may help to keep high-risk COVID-19 patients out of the hospital,” said Patrizia Cavazzoni, director of the FDA’s center for drug evaluation. and Research, said in a release.
“We call on 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,” Cavazzoni added.
The emergency permit for COVID-19 treatment granted only on bamlanivimab was the first monoclonal antibody approved for the treatment of mild to moderate COVID-19 cases in November. It was originally allowed to be used only for mild to moderate adult patients with COVID-19 and some children at high risk for severe coronavirus disease or hospitalization.
The federal agency said it would work with the Centers for Disease Control & Prevention (CDC) and the National Institutes of Health (NIH) to monitor how variants affect the treatments allowed for emergency use.
Eli Lilly urges FDA to end emergency clearance for the treatment of COVID-19 alone with bamlanivimab ‘because of the changing landscape in the USA and the full availability of bamlanivimab and etesevimab together.’ The company noted that the request for revocation was “not due to any new security issue.”
The company reported that more than 400,000 patients had been treated with bamlanivimab, saying it could have prevented more than 20,000 hospitalizations and at least 10,000 deaths in the US.
“With the increasing prevalence of variants in the US that bamlanivimab alone may not be fully neutralized, and with sufficient stock of vivabab stock, we believe now is the right time to complete our planned transition and focus on administration. of these two neutralizing antibodies together, “Eli Lilly’s chief scientific officer and president of Lilly Research Laboratories Daniel Skovronsky said in the release.
Eli Lilly’s request comes after the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response declared in March that the US had stopped using bamlanivimab alone. to treat COVID-19.