GSK-Vir’s Sotrovimab No Longer Authorized to Treat COVID-19 in U.S.April 6, 2022
FDA said that GSK-Vir’s sotrovimab is not authorized in any U.S. state or territory at this time, as CDC’s data showed the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant.
The Centers for Disease Control and Prevention (CDC) Nowcast data has estimated that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is above 50% in all Health and Human Services (HHS) U.S. regions. Data included in the health care provider fact sheet showed the said dose is unlikely to be effective against the BA.2 sub-variant.
FDA also noted thar the health care providers should use other approved or authorized products as they choose appropriate treatment options for patients.
Earlier this year FDA limited use of Sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 Omicron sub-variant.
In May 2021, GSK and Vir Biotechnology announced that Sotrovimab (VIR-7831) received emergency use authorization from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and pediatric patients.
At the moment of publishing this article we did not get the comment from GSK, neither Vir Biotechnology.