On Friday 7 May, the European Medicines Agency (EMA) announced that it had started a rolling review of a new treatment for Covid-19.Sotrovimab is a monoclonal antibody treatment also known as VIR-7831 and GSK4182136, which was developed by the British pharmaceutical giant GSK and the American company Vir Biotechnology Inc.
This decision was based on preliminary results of a study on the drug’s ability to prevent hospitalisation or death in non-hospitalised patients with the virus, the European Agency said in a press release.
The EMA has started to evaluate the first batch of data from laboratory and animal studies and data on the drug’s quality. However, the EMA said it was still too early to draw any conclusions regarding the drug’s potential risks and benefits.
Therefore, the Agency will continue its review until sufficient evidence is available to support a formal application for market authorisation.
It also stressed, “a separate review of sotrovimab is already underway to provide EU-wide recommendations to support national authorities who may decide on the use of the Covid-19 drug before market authorisation”.
The announcement comes a day after the European Commission presented a strategy to ensure access to future anti-Covid-19 treatment options across the EU (see EUROPE 12714/11).
The Commission estimates that three of these treatment options could obtain market authorisation by October 2021. Sotrovimab is the fourth candidate treatment to undergo a rolling review by the EMA. The other three, including a monoclonal antibody treatment and two antibody combinations, began in February and March. (Original version in French by Agathe Cherki)