The Food and Drug Administration (FDA) has revised the authorization for sotrovimab to limit its use for the treatment of COVID-19 in certain US states and territories with a high prevalence of the BA.2 Omicron subvariant.
According to recent data, the authorized dose of sotrovimab is unlikely to be effective against the BA.2 subvariant. As of March 29, 2022, the Centers for Disease Control and Prevention Nowcast data reported that the BA.2 subvariant accounted for more than 50% of cases in the states and territories listed below.
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 the following states and territories:
- Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont (Health and Human Services [HHS] Region 1)
- New Jersey, New York, Puerto Rico, and the Virgin Islands (HHS Region 2)
- Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin (Region 5) (as of 3/30/2022)
- Arizona, California, Hawaii, Nevada, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands, and Republic of Palau (Region 9) (as of 3/30/2022)
- Alaska, Idaho, Oregon, and Washington (Region 10) (as of 3/30/2022)
Sotrovimab remains authorized in US regions where the CDC Nowcast point estimate for the proportion of the Omicron BA.2 variant remains below 50%.
In a statement, the FDA noted that alternative therapies such as Paxlovid, Veklury (remdesivir), bebtelovimab, and molnupiravir 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. Health care providers in regions where sotrovimab remains authorized should strongly consider the use of alternative therapies and monitor the frequency of the BA.2 subvariant in their region.
Editor’s Note: This article was updated on April 1, 2022.
FDA updates sotrovimab emergency use authorization. News release. US Food and Drug Administration. March 30, 2022. Accessed April 1, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization