FDA Updates Fact Sheets For Eli Lilly, Regeneron's COVID-19 Antibody Therapies Under Emergency Use

The FDA updated its fact sheets on the monoclonal antibody (mAb) treatments for COVID-19 from Eli Lilly And Co LLY and Regeneron Pharmaceuticals Inc REGN, highlighting additional data on the vulnerability of the emerging COVID-19 variants to each of the mAb therapies.

• “Some variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19,” FDA said. “Health care providers should review the authorized fact sheets for information on the use of the authorized mAb therapies against currently circulating viral variants.”
• The U.S. government stopped the distribution of Lilly’s bamlanivimab, in California, Nevada, and Arizona because of the variant originating in California.
• As per FDA’s revised fact sheet for bamlanivimab, a substantial reduction in responsiveness to mAb therapies was observed for all the variants studied, except for the one originating in the U.K.
• Updated fact sheet showed that Lilly’s combination therapy of bamlanivimab and etesevimab was better against all variants than bamlanivimab alone.
• Updated fact sheet for Regeneron’s cocktail therapy combining casirivimab and imdevimab showed a minimum reduction in susceptibility against the variants.
• Price Action: LLY shares were up 0.3% at $184.50, and REGN shares were trading 0.98% higher at $479.3 in market trading hours on the last check Friday.