GSK and Vir Report Initiation of EMA Rolling Review of VIR-7831 (sotrovimab) for the Early Treatment of COVID-19

May 10, 2021 Auto Bot GSK, regulatory, sotrovimab, Vir, VIR-7831 0

Shots:

  • The rolling review will assess sotrovimab in adults and adolescents (aged 12yrs.) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The rolling review will support a formal MAA
  • EMA’s CHMP will review the data and the decision to start the rolling review is based on a P-III COMET-ICE study that demonstrated an 85% reduction in hospitalizations over 24hrs. or deaths in those receiving sotrovimab vs PBO
  • Additionally, the CHMP is also reviewing sotrovimab under Article 5(3) of Regulation 726/2004 The companies will continue discussions with global regulators to make sotrovimab available to patients with COVID-19

Click here to­ read full press release/ article | Ref: GSK | Image: GSK

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