Sanofi: CHMP recommends approval of Beyfortus

(CercleFinance.com) - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion and recommends approval of Beyfortus (nirsevimab) for the prevention of lower respiratory tract infections caused by RSV in newborns and infants.


If approved, Beyfortus will become the first and only single-dose passive immunisation agent indicated for all infants, including healthy, full-term and premature infants and those with certain health problems.

Beyfortus is jointly developed by Sanofi and AstraZeneca.

This positive opinion is one of the most important advances in terms of public health and the fight against RSV for several decades, the group said.

Trials have shown that a single dose of Beyfortus reduces the incidence of lower respiratory tract infections caused by RSV that require medical attention during the RSV season.


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