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GlaxoSmithKline PLC said on Friday that the US Food & Drug Administration has amended the emergency use authorization fact sheet for sotrovimab, an investigational Covid-19 neutralizing monoclonal antibody.
The Brentford, England-based pharmaceutical company explained that the FDA determined that it is unlikely that the sotrovimab 500 milligram dose will be effective against the Omicron BA.2 variant.
GSK and Vir Biotechnology Inc are now preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 sub-variant and will be sharing these data with regulatory and health authorities around the world for discussion.
Sotrovimab is authorized for emergency use in the United States and has been granted a marketing authorization in the European Union as well as conditional marketing authorization in the UK.
Shares in GSK closed down 0.2% at 1,623.20 pence on Friday in London.
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