GlaxoSmithKline, Vir snag FDA authorization for new COVID-19 antibody. But how will they sell it without a supply deal?
Following in the footsteps of Eli Lilly and Regeneron, a partnership between GlaxoSmithKline and Vir Biotechnology has won an emergency FDA nod for a COVID-19 antibody drug. The difference? It doesn’t have a supply deal with the U.S. government. Wednesday, the FDA issued (PDF) an emergency use authorization to GSK and Vir’s sotrovimab for mild-to-moderate COVID-19. Same as the previous go-aheads for similar therapies from Lilly and Regeneron, the new nod is limited to patients who aren’t hospitalized but are at high risk of progressing to severe disease. The anti-coronavirus antibody proved its worth in a phase 3 trial. The Comet-Ice study stopped early after an interim analysis found sotrovimab reduced the number of patients who died or needed hospitalization by 85% over placebo.
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