Sanofi gets European Commission nod for Beyfortus to prevent RSV disease in infants

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 RSV disease. Once launched, Beyfortus will offer parents the ability to help protect their babies during their first RSV season."

Iskra Reic, Vaccines and Immune Therapies Unit, AstraZeneca said, "Beyfortus is the first single-dose passive immunization against respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population. The marketing authorization of Beyfortus marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention."

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."

The European Commission is the first regulatory body to grant approval to Beyfortus. The approval was based on results from the Beyfortus clinical development program, including the Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b 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 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 vs. placebo with a single dose. The safety profile of Beyfortus was similar to the placebo. Beyfortus also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.

RSV is the most common cause of LRTI, including bronchiolitis and pneumonia, in infants. It is also a leading cause of hospitalization in all infants, with most hospitalizations for RSV occurring in healthy infants born at term. Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations, 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.