Therapy has been developed for the prevention of disease in infants.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Beyfortus for the prevention of respiratory syncytial virus (RSV) and lower respiratory tract disease in newborns and infants.

If approved, Beyfortus – also known as nirsevimab – would be the first and only single-dose passive immunisation for the wider infant population, including those born healthy, at term or preterm, or with specific health conditions. Beyfortus is being developed jointly by Sanofi and AstraZeneca.

The CHMP based its positive opinion on results from the Beyfortus clinical development program, including the MELODY and phase 2b trials.

During the MELODY and phase 2b trials, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season versus placebo with a single dose. The safety profile of Beyfortus was similar to placebo. Beyfortus also demonstrated comparable safety and tolerability profile to palivizumab in the MEDLEY trial.

Jean-François Toussaint, global head of research and development vaccines at Sanofi, explained: “Today’s positive CHMP opinion is one of the most significant public health achievements in RSV in decades and has the potential to alleviate the enormous physical and emotional burden that RSV can place on families and healthcare systems. With this endorsement, we are one step closer to achieving our goal of protecting all infants against RSV with a single dose.”

Iskra Reic, executive vice president, vaccines and immune therapies at AstraZeneca, added: “This positive CHMP opinion underscores Beyfortus’ potential as a ground-breaking, first-in-class passive immunisation that could transform the medical community’s approach to RSV prevention in infants.”

RSV is the most common cause of LRTIs and a leading cause of hospitalisation in all infants, with most 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.