FDA Pulls Emergency Use Authorization For Lilly's COVID-19 Antibody Drug

The U.S. Food and Drug Administration has pulled its emergency-use authorization for bebtelovimab, a COVID-19 antibody co-developed by Eli Lilly & Co. (LLY) and AbCellera Biologics Inc. (ABCL), after determining that the drug is not expected to neutralize the two new Omicron subvariants BQ.1 and BQ.1.1.

The drug received the authorization from the FDA in February.

The FDA on Wednesday said data from the Centers for Disease Control and Prevention published last week estimates that the combined proportion of COVID-19 cases caused by the Omicron BQ.1 and BQ.1.1 subvariants to be above 57% nationally, and already above 50% in all individual regions.

"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.

According to the FDA, Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice by the Agency. Additionally, the Administration for Strategic Preparedness and Response has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative.

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