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

  Ref: GSK | Image: GSK