Europe – CHMP recommends 12 new medicines, including first RSV treatment for infants

The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to prevent respiratory syncytial virus (RSV) in newborns, driving the total number of endorsed treatments to 70 since the beginning of the year. Five of the 12 approval recommendations are for orphan drugs.

The new RSV treatment, Beyfortus (nirsevimab) developed by AstraZeneca and Sanofi, was supported through EMA’s PRIME scheme, which allows for early and enhanced regulatory support for unmet medical needs.

In its review, CHMP concluded that data from two randomized, double-blind, placebo-controlled  multicenter clinical trials demonstrated the treatment “prevents lower respiratory tract infection caused by RSV requiring medical attention (such as bronchiolitis and pneumonia) in term and preterm infants during their first RSV season.”…