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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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