16 September 2022 07:00 BST
Beyfortus (nirsevimab) recommended for approval in the EU by CHMP for the prevention of RSV lower respiratory tract disease in infants
Recommendation is based on the Beyfortus clinical trial programme which demonstrated protection against RSV disease during the RSV season with a single dose
If approved by the European Commission, Beyfortus would be the first preventative option for the broad newborn and infant population
AstraZeneca and Sanofi's Beyfortus (nirsevimab) has been recommended for marketing authorisation in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. 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.1-8
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.1-6 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.7-8
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “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 respiratory syncytial virus prevention in infants.”
Jean-François Toussaint, Global Head of Research and Development Vaccines, Sanofi, said: “Today's positive CHMP opinion is one of the most significant public health achievements in respiratory syncytial virus 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.”
RSV is the most common cause of LRTIs and a leading cause of hospitalisation in all infants .9-11 RSV-related direct medical costs, globally – including hospital, outpatient and follow-up care – were estimated at €4.82 billion in 2017.12 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.13-14