The Food and Drug Administration on Wednesday paused the authorization of Eli Lilly and Co.’s bebtelovimab drug, stating that it is not effective at neutralizing the BQ.1 and BQ.1.1 subvariants of the COVID-19 Omicron virus.
The two subvariants account for 57% of current COVID-19 cases in the U.S., according to the Centers for Disease Control and Prevention.
“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.
Eli Lilly and its distributors have paused commercial distribution of the drug bebtelovimab until the FDA provides further notice. The FDA has recommended that remaining supplies of the drug be retained in case a different variant that the drug suppresses becomes more prevalent.
“Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate COVID-19 with bebtelovimab in the US,” the pharmaceutical company said in a statement. “Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants.”
The FDA’s announcement leaves three treatment products for the BQ.1 and BQ 1.1 subvariants: Pfizer’s Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury.
The utilization of convalescent plasma is also an approved treatment option for immunosuppressed COVID patients.
The FDA said it will continue to work with the CDC, the Administration for Strategic Preparedness and Response, and the National Institutes of Health on the “surveillance of variants that may impact the use of the therapies authorized for emergency use.”
