Therapy Areas: Respiratory
Sanofi and AstraZeneca's Beyfortus recommended by CHMP for prevention of RSV disease in infants
16 September 2022 -

French healthcare company Sanofi SA (Euronext Paris:SAN) (NASDAQ:SNY) announced on Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.

Beyfortus, an investigational long-acting antibody, is being developed jointly by Sanofi and AstraZeneca (STO:AZN) (LON:AZN) (Nasdaq:AZN).

If approved by the EMA, Beyfortus would be the first and only single-dose passive immunisation for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.

The CHMP based its positive opinion on trial results which demonstrated reduced incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season vs. placebo with a single dose.

RSV is the most common cause of LRTIs and a leading cause of hospitalisation in all infants, with most hospitalisations occurring in infants born healthy and at term. Currently there is no preventative option available for all infants and treatment is limited to symptomatic relief.

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