The Food and Drug Administration on Friday reversed its emergency use authorization for sotrovimab, the monoclonal antibody used to treat COVID-19, in eight states, Puerto Rico, and the U.S. Virgin Islands, because it is not effective against the new BA.2 variant.
"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, Vermont, New Jersey, New York, Puerto Rico, and the Virgin Islands," the agency announced Friday.
"New data included in the healthcare 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."
According to the agency, sotrovimab is used for the treatment of "mild-to-moderate" COVID-19 in adults and children over the age of 12 and who are at "high risk" for progressing to severe COVID-19, including hospitalization and death.
The drug is still authorized in other states and regions where there is a different dominant variant than BA.2, the agency said.
The BA.2 omicron variant accounts for almost 35% of COVID-19 cases nationwide as of March 19 but has dramatically risen in regions 1 and 2 in the northeast to more than 50% of cases, according to the CDC.
As an alternative, the FDA said that other therapeutics including Paxlovid, Veklury (remdesivir), bebtelovimab, and Lagevrio (molnupiravir), which the agency believes are effective against the BA.2 variant and are authorized to treat certain patients with mild-to-moderate COVID-19 are still available in those 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," the FDA announcement said. "Healthcare providers should also monitor the frequency of BA.2 in their region as they choose appropriate treatment options for patients."
As of Thursday, the CDC reported 39,076 new COVID-19 cases and 894 deaths nationwide.
The agency also reports that 65.5% of the population is fully vaccinated, and 76.8% have had at least one dose of the available vaccines.
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