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 response, Vir Biotechnology (VIR) said in a regulatory filing that the company would continue to recognize about $1.1 billion of collaboration revenues when Sotrovimab doses are delivered in 1H 2022. The partners plan to manufacture approximately 2 million doses in 1H 2022 and additional doses in 2H 2022.
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.