Tuesday 5th of April 2022 06:33:41 PM

GlaxoSmithKline, Vir COVID-19 therapy is no longer authorized in U.S. - FDA

Headquarters of US Food and Drug Administration (FDA) Grandbrothers/iStock Editorial via Getty Images
  • The U.S. Food and Drug Administration (FDA) said on Tuesday that Sotrovimab — the COVID-19 antibody therapy developed by GlaxoSmithKline (NYSE:GSK) and Vir Biotechnology (NASDAQ:VIR) — is no longer authorized in the U.S. due to a surge in cases caused by the Omicron BA.2 sub-variant.
  • Issuing a statement, the federal agency said that the authorized dose of Sotrovimab was unlikely to be effective against the highly contagious variant, which has become the dominant strain of COVID-19 in the U.S., according to the latest data from the Centers for Disease Control and Prevention (CDC).
  • “Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients,” it added.
  • In January, the FDA pulled authorizations for rival antibody therapies from Regeneron (REGN) and Eli Lilly (LLY), noting that they were ineffective against the original version of the Omicron variant.
  • However, in February, the regulator greenlighted another antibody therapy from Eli Lilly (LLY) known as bebtelovimab that retains efficacy against the Omicron variant.


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