The European Medicines Agency (EMA) published on Friday 24 February the main decisions of its Committee for Medicinal Products for Human Use (CHMP) and two decisions concerning medical products related to Covid-19.
On the one hand, CHMP recommends authorising the use of the inactivated and adjuvanted vaccine developed against Covid-19 by Valneva (see EUROPE 12980/20) for use as a booster dose in adults aged 18-50 years.
In addition, the CHMP reviewed all data received in the context of the evaluation of the investigational broad-spectrum antiviral drug Lagevrio (molnupiravir), developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics, for potential European market authorisation for use against Covid-19.
The CHMP considered that it could not conclude that Lagevrio could reduce the risk of hospitalisation or death or even shorten the duration of the disease or recovery period in adults at risk of developing a severe form of the disease.
The EMA further points out that it has not been possible to identify a specific group of patients in whom a clinically relevant benefit of Lagevrio could be demonstrated.
Based on these findings, the EMA CHMP recommended that the market authorisation of Lagevrio for the treatment of Covid-19 in adults be refused. (Original version in French by Émilie Vanderhulst)