Beyfortus recommended for approval in the EU by CHMP for the prevention of RSV lower respiratory tract disease in infants

If approved, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Authority based its positive opinion on results from the Beyfortus clinical development programme, including the MELODY Phase III, MEDLEY Phase II/III, and Phase IIb trials.

In the MELODY and Phase IIb 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 vs. placebo with a single dose. No clinically meaningful differences in safety results between the Beyfortus and placebo groups were seen. Beyfortus also demonstrated a comparable safety and tolerability profile to Synagis (palivizumab) in the MEDLEY Phase II/III trial, with occurrence of treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) similar between groups.

RSV is the most common cause of LRTIs and a leading cause of hospitalisation in all infants. RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care — were estimated at €4.82 billion in 2017. The current standard of care for the prevention of serious LRTIs caused by RSV focuses on to preterm infants and infants at higher risk of severe disease, and treatment is limited to symptomatic relief.

Beyfortus (nirsevimab), an investigational long-acting antibody designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose, is being developed jointly by AstraZeneca and Sanofi using AstraZeneca’s YTE technology.

In March 2017, AstraZeneca and Sanofi announced an agreement to develop and commercialise nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities, and Sanofi will lead commercialisation activities and record revenues.