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FDA Limits Use Of Sotrovimab To Treat COVID-19 In Some US Regions Due To BA.2 Omicron Sub-variant

The Food and Drug Administration has limited the use of GlaxoSmithKline PLC and Vir Biotechnology Inc.'s sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 Omicron sub-variant.

The FDA on Friday said that it 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.

Sotrovimab is no longer authorized for use in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, Puerto Rico, and the Virgin Islands.

New data 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.

The FDA said that there are several other therapies, including 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.

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