September batch of recommendations from EMA/CHMP

The European Medicines Agency’s (EMA) human medicines committee (CHMP) today released its list of recommended novel medicines and one biosimilar for approval following its September 2022 meeting. These will now be passed to the European Commission for a final decision.

The CHMP recommended granting a marketing authorization for AstraZeneca (LSE: AZN) and Sanofi’s (Euronext: SAN) Beyfortus (nirsevimab) intended for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season (when there is a risk of RSV infection in the community). Beyfortus was supported through the EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs.

The committee adopted a positive opinion for Enjaymo (sutimlimab) from Sanofi subsidiary Genzyme, for the treatment of hemolytic anemia (breakdown of red blood cells) in adult patients with cold agglutinin disease, a rare autoimmune disorder characterized by the premature destruction of red blood cells.