Lilly's Antibody Receives FDA Emergency Use Nod For Mild-To-Moderate COVID-19

The FDA on Friday authorized Eli Lilly And Co's LLY COVID-19 antibody drug for people aged 12 and older at risk of severe illness.

  • The FDA authorized bebtelovimab for emergency use in patients with mild-to-moderate COVID-19 who are at high risk of progression to severe disease, including hospitalization or death.
  • Bebtelovimab should be used when alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate, the agency said.
  • Earlier this month, Lilly announced COVID-19 antibody sales of $2.24 billion for 2021, with $1.06 billion coming in the fourth quarter.
  • In January, the FDA revised the emergency use authorizations for Lilly's antibody combination treatment and Regeneron Pharmaceuticals Inc REGN after the drugs were ineffective against the omicron variant.
  • Lilly has said bebtelovimab retains activity against omicron and its BA. 2 subvariant, which is said to be more transmissible.
  • The Company signed bebtelovimab supply deal with the U.S. government for up to 600,000 doses for at least $720 million to be delivered by the end of March.
  • Bebtelovimab was originally discovered by AbCellera Biologics Inc ABCL and later licensed and developed by Eli Lilly.
  • Price Action: LLY shares closed at $235.61 on Friday. ABCL shares are up 0.73% at $9.71 during the premarket session on the last check Monday.
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