AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved 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. Beyfortus is the first and only single-dose RSV passive immunisation for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.
RSV is a common and highly contagious seasonal virus, infecting nearly all children by the age of two.
The European Commission is the first regulatory body to grant approval to Beyfortus. The approval was based on results from the Beyfortus clinical development programme, including the MELODY Phase III, MEDLEY Phase II/III and Phase IIb trials, and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September 2022.
In the pivotal MELODY efficacy trial, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV by 74.5% (95% CI 49.6, 87.1; p<0.001) vs. placebo through day 151 (a typical RSV season) with a single dose. 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.
Silke Mader, chairwoman of the Executive Board and co-founder of the European Foundation for the Care of Newborn Infants (EFCNI), said: “Respiratory syncytial virus represents a health threat among infants, and each year we see the impact it can have on families, healthcare providers and the healthcare system. At EFCNI, we are excited about the opportunity to expand prevention efforts to all infants, as we believe this can help ease the current emotional, physical and financial burdens of RSV.”
Iskra Reic, executive vice president, Vaccines and Immune Therapies, AstraZeneca, said: “Beyfortus is the first single-dose preventative option against respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population. Today’s marketing authorisation of Beyfortus marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention.”
Thomas Triomphe, executive vice president, Vaccines, Sanofi, said: “Today is a landmark day for RSV prevention, as decades of research and development come together in the world’s first approval of a broadly protective option against respiratory syncytial virus disease. Once launched, Beyfortus will offer parents the ability to help protect their babies during their first RSV season.”
RSV is the most common cause of LRTI, including bronchiolitis and pneumonia in infants. It is also a leading cause of hospitalisation in all infants. Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalisations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years. RSV-related direct medical costs, globally – including hospital, outpatient and follow-up care – were estimated at €4.82 billion in 2017.
