FDA Withdraws Authorization for Last Remaining COVID-19 Monoclonal Antibody Treatment

The FDA has withdrawn its authorization for Eli Lilly’s bebtelovimab because it is not believed to be effective against Omicron subvariants BQ.1 and BQ.1.1, which comprise 57 percent of COVID-19 cases nationally.

Bebtelovimab is a monoclonal antibody for intravenous use under Emergency Use Authorization to treat adult and pediatric patients 12 years and older and weighing at least 88 pounds who have mild-to-moderate COVID-19, are at risk of progressing to severe COVID-19 and for whom alternative authorized or approved COVID-19 treatments are not possible.

The drugs the FDA has deemed effective against the two subvariants are Pfizer’s Paxlovid (nirmatrelvir, ritonavir), Gilead Sciences’ Veklury (remdesivir) and Merck’s Lagevrio (molnupiravir) as well as convalescent plasma with high titers of anti-COVID antibodies.

“Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice,” the agency said.