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

Nov. 30, 2022, 7:58 PM

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 ...