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GSK and Vir’s Xevudy (sotrovimab) Receive EC's Marketing Authorization for the Treatment of COVID-19

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GSK and Vir’s Xevudy (sotrovimab) Receive EC's Marketing Authorization for the Treatment of COVID-19

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  • The EC has granted marketing authorization for Xevudy in adults & adolescents aged ≥12yrs. with COVID-19 who do not require supplemental oxygen & are at increased risk of progressing to sev. COVID-19
  • The authorization is based on the P-III (COMET-ICE) trial to evaluate sotrovimab vs PBO for COVID-19. The trial met its 1EPs i.e., 79% reduction in all-cause hospitalizations for 24+ hrs. or death due to any cause @29Day, 30 (6%) out of 529 patients in the PBO were progressed vs  6 (1%) received sotrovimab & was well-tolerated
  • Xevudy is a SARS-CoV-2 neutralizing mAb & is authorized for EUA in the US. In in-vitro data, sotrovimab retains activity against VOC & interest of the SARS-CoV-2 virus

Ref: GSK | Image: GSK

Click here to­ read the full press release 

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