European Medicines Agency starts rolling review of sotrovimab (VIR-7831) for COVID-19
The decision to start the rolling review was based on preliminary results from an ongoing study evaluating it in the treatment of non-hospitalised patients with Covid-19. The review will continue until enough evidence is available to support a marketing authorisation application.
Source:
European Medicines Agency
SPS commentary:
A separate review of sotrovimab (VIR-7831), a monoclonal antibody that attaches to the spike protein of SARS-CoV-2 and reduces its ability to enter body cells, is already underway to provide EU-wide recommendations to support national authorities who may decide to use it prior to marketing authorisation.