March 25, 2022
1 min read
The monoclonal antibody sotrovimab is no longer authorized by the FDA to treat COVID-19 in certain U.S. regions with high frequency of the omicron BA.2 subvariant.
In a statement released March 25, the FDA said it was limiting the use of sotrovimab (Xevudy, GlaxoSmithKline) in some U.S. regions, mostly along the east coast, following data showing that the authorized dose of the monoclonal antibody — 500 mg — is unlikely to be effective against the BA.2 subvariant.
Regions where sotrovimab is no longer authorized for COVID-19 treatment, until further notice, are:
- New Hampshire;
- New Jersey;
- New York;
- Puerto Rico;
- Rhode Island;
- Vermont; and
- The U.S. Virgin Islands.
Based CDC Nowcast data, the BA.2 subvariant is estimated to account for more than 50% of cases in these states and territories as of March 19, 2022.
According to the FDA, other therapies, including antivirals nirmatrelvir (Paxlovid, Pfizer), remdesivir (Veklury, Gilead Sciences) and molnupiravir (Lagevrio, Merck), as well as the monoclonal antibody bebtelovimab (LY-CoV1404, Eli Lilly), are expected to be effective against the BA.2 sub-variant. These treatments remain authorized or approved to treat certain patients with mild-to-moderate COVID-19, who are at high risk for progression to severe disease, in these regions.
“We will continue to monitor BA.2 in all U.S. regions and may revise the authorization further to ensure that patients with COVID-19 have effective treatments available,” read the FDA statement, in part. “Health care providers should also monitor the frequency of BA.2 in their region as they choose appropriate treatment options for patients.”