The U.S. Food and Drug Administration is no longer approving the monoclonal antibody treatment, sotrovimab, in 10 states and territories due to doubts about its efficacy against the BA.2 Omicron subvariant.
The FDA revoked sotrovimab’s emergency use approval in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey and New York, as well as in Puerto Rico and the Virgin Islands.
The agency writes that “the approved dose of sotrovimab is unlikely to be effective against the BA.2 subvariant.”
The new subvariant accounts for more than 50% of all COVID-19 variants in the eight states and two territories listed by the agency. Health care providers will no longer be able to treat patients in these areas with sotrovimab, and in other regions they will be instructed to monitor the BA.2 subvariant before deciding which antibody treatment to ban.
Other monoclonal antibody therapies such as Paxlovid and Veklury (remdesivir) still appear to be effective against the Omicron subvariant, the FDA said.
The other treatments are “approved or approved to treat certain patients with mild to moderate COVID-19 who are at high risk of progression to serious illness, including hospitalization or death,” according to the agency.
The FDA signaled in February that it would restrict the use of sotrovimab as needed due to its effectiveness against the subvariant.