Source: The Hill
The Food and Drug Administration (FDA) recently said that the COVID-19 monoclonal antibody treatment bebtelovimab from Eli Lilly is no longer authorized for emergency use in the U.S. as it is not expected to be effective at neutralizing the two most dominant omicron subvariants in the country right now.
The omicron subvariants BQ.1 and BQ.1.1 collectively account for 57.3% of COVID-19 cases in the U.S. right now, having pushed the BA.5 omicron subvariant out as the dominant subvariant earlier this month.
- “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.
- “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 U.S.,” Eli Lilly said in a statement, confirming that its monoclonal antibody treatment does not appear to neutralize the BQ.1 and BQ.1.1 subvariants.
The FDA stated that Eli Lilly and its distributors have paused distribution of bebtelovimab until further notice and the Administration for Strategic Preparedness and Response has also paused the fulfillment of any pending requests for the drug.
Bebtelovimab was the last monoclonal antibody authorized for treating COVID-19. Other previous antibody treatments have been withdrawn from the market.
With this treatment no longer being distributed or authorized for use, the FDA advised that physicians and other health care professionals choose “appropriate” treatments including the authorized antivirals Paxlovid, Veklury and Lagevrio.