The FDA revoked the emergency use authorization for the monoclonal antibody Sotrovimab in the Northeastern US due to its ineffectiveness against the Omicron BA.2 subvariant. The drug is manufactured and distributed by GlaxoSmithKline.
The agency says the monoclonal antibody sotrovimab should not be used in the US Health and Human Services (HHS) regions 1 and 2 due to the high frequency of the Omicron BA.2 sub-variant and data showing that the authorized dose is unlikely to be effective against that sub-variant.
- HHS Region 1: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont
- HHS Region 2: New Jersey, New York, Puerto Rico, and the Virgin Islands
“Sotrovimab may not be administered for treatment of COVID-19 in these regions under the emergency use authorization until further notice by the agency,” an FDA alert says.
Monoclonal antibody Sotrovimab (500 mg) was authorized in May 2021 by the FDA for intravenous use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
According to the CDC, the Omicron BA.2 subvariant now makes up 12.6% of all COVID-19 infections in the United States (as of Mar 5, 2022 data). However, in the Northeastern US, BA.2 prevalence is 2-3 times the national rate, at 23.1% in HHS Region 1 (CT, ME, MA, NH, RI, VT) and 32.6% in HHS Region 2 (NJ, NY, PR, VI).
