Therapeutics Strategy – First rolling review of a new COVID-19 medicine

The European Medicines Agency has today started the rolling review of sotrovimab (VIR-7831), a monoclonal antibody developed for the treatment of COVID-19. The review follows hot on the heels of the EU COVID-19 Therapeutics Strategy presented yesterday and is a first step towards the Strategy’s target of starting seven rolling reviews of COVID-19 therapeutics in 2021. The rolling review launched by EMA will assess sotrovimab’s effectiveness in preventing hospitalisation and death; safety and quality. A rolling review is quicker than a regular evaluation as data is reviewed as it comes in. Should the European Medicines Agency recommend authorising the treatment at the end of its review, the European Commission will move swiftly to authorise it. The EU Therapeutics Strategy supports the development and availability of much needed COVID-19 therapeutics and covers the lifecycle of medicines: from research, development and manufacturing to procurement and deployment. It is part of the strong European Health Union, in which all EU countries prepare and respond together to health crises and ensure the availability of affordable and innovative medical supplies – including the therapeutics needed to treat COVID-19. More details on the EU Therapeutics Strategy are available in a press release and factsheet.