USFDA amends emergency use authorization for Sotrovimab due to Omicron BA.2 Subvariant
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San Francisco: GlaxoSmithKline plc and Vir Biotechnology, Inc. have announced that the US Food and Drug Administration (USFDA) has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an investigational monoclonal antibody.
The FDA has determined that, based on the totality of available evidence, including new live virus data generated by Vir, it is unlikely that the sotrovimab 500 mg dose will be effective against the Omicron BA.2 variant. GSK and Vir are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant and will be sharing these data with regulatory and health authorities around the world for discussion.
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