Update [3/25/2022] FDA limits use of Sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 Omicron sub-variant
This statement updates and replaces the original statement below from 2/25/22.
The U.S. Food and Drug Administration is continually monitoring how authorized and approved treatments for COVID-19 are affected by changing variants—currently Omicron and the Omicron sub-variants, such as BA.2. Today, considering the most recent data available, FDA is announcing that 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)
New data included in the health care provider fact sheet shows that the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Based on Centers for Disease Control and Prevention Nowcast data, the BA.2 sub-variant is estimated to account for more than 50% of cases in the states and territories in Regions 1 and 2 listed above as of March 19, 2022.
There are several other therapies – Paxlovid, Veklury (remdesivir), bebtelovimab, and Lagevrio (molnupiravir) – that are expected to be effective against the BA.2 sub-variant, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether these treatments are right for their patients.
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. Health care providers should also monitor the frequency of BA.2 in their region as they choose appropriate treatment options for patients.
[2/25/2022] On February 23, 2022, FDA revised the emergency use authorization for sotrovimab to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment. However, sotrovimab is currently authorized in all U.S. regions until further notice by FDA. For other limitations and conditions, refer to the emergency use authorization (EUA).
FDA will continue to monitor conditions to determine whether use in a geographic region is consistent with the scope of authorization, referring to available information, including information on variant susceptibility and CDC regional variant frequency data.
This EUA authorizes sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients 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. Sotrovimab should be administered by a qualified health care provider as a single intravenous infusion (IV) as soon as possible after positive viral test for COVID-19 and within seven days of symptom onset.