Eli Lily Loses FDA Authorization for Covid Bebtelovimab Drug

The Food and Drug Administration has pulled U.S authorization for Eli Lilly and Co’s (NYSE: LLY) Covid-19 drug Bebtelovimab. The agency made the call after citing that the treatment is not effective against emerging omicron subvariants such as BQ.1 and BQ.1.1.

“Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time,” the FDA said in a statement.

Nevertheless, according to the agency, bebtelovimab supply should be kept readily available in case the Covid variants which the treatment can neutralize become dominant again at any time. Eli Lily has already halted all commercial distribution of the antibody treatment until further notice.

“Lilly continually monitors the global COVID-19 environment, assessing the neutralization activity of potential antibody therapies against a wide array of existing and emerging mutations and variants,” said the company. “Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants.”

Bebtelovimab is a single-dose injection given to people who get Covid and are at high risk of developing severe disease but are not able to take any other FDA-Approved treatments like the oral antiviral Paxlovid. People with weak immune systems, like organ transplant patients, are not able to take Paxlovid with other medications they need.