Sotrovimab is no longer authorized for emergency use to treat COVID-19 in any US state or territory at this time, according to an updated alert from the Food and Drug Administration (FDA).
According to recent data, the authorized dose of sotrovimab is unlikely to be effective against the Omicron BA.2 subvariant. As of April 5, 2022, the Centers for Disease Control and Prevention Nowcast data reported that the BA.2 subvariant accounted for more than 50% of cases in all US states and territories.
The FDA has updated the Fact Sheets for Health Care Providers for sotrovimab with information regarding the expected activity against the SARS-CoV-2 Omicron B.1.1.529/BA.2 variant. Sotrovimab is no longer authorized for use at this time in any US region.
Health care providers are advised to use alternative therapies such as Paxlovid, Veklury, bebtelovimab and molnupiravir, which are expected to work against the BA.2 subvariant. These treatments are authorized or approved to treat patients with mild to moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.
FDA updates sotrovimab emergency use authorization. News release. US Food and Drug Administration. Accessed April 5, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization
Source: Medical Bag https://www.medicalbag.com/home/news/fda-sotrovimab-no-longer-authorized-to-treat-covid-19-in-any-us-region/