FDA revises emergency use authorization for sotrovimab due to Omicron BA.2 subvariant of COVID 19.
GlaxoSmithKline plc and Vir Biotechnology, Inc. announced that the FDA 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 subvariant.
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.
The FDA has updated its website to exclude sotrovimab use in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information, including variant susceptibility to these drugs and regional variant frequency (HHS regions 1 and 2). The FDA will continue to monitor the prevalence of circulating variants and update its website accordingly.
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