FDA Pauses Authorization for Lilly’s Bebtelovimab Covid Drug (1)

The FDA says Eli Lilly’s bebtelovimab is not currently authorized for emergency use in the US because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.

• FDA says 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
• FDA says Data from CDC last week estimates combined proportion of Covid cases caused by BQ.1 and BQ.1.1 subvariants to be above 57% nationally and data shows a sustained ...