AstraZeneca PLC (LSE:AZN) said its Beyfortus (nirsevimab) immunisation developed with France's Sanofi has been approved in the EU for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in 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 or with specific health conditions, AstraZeneca said.
RSV is a common and highly contagious seasonal virus, infecting nearly all children by the age of two. It is the most common cause of LRTI, including bronchiolitis and pneumonia in infants, and is also a leading cause of hospitalisation in all infants.
The European Commission is the first regulatory body to grant approval to Beyfortus. Its decision followed positive opinion from The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September.
“Today's marketing authorisation of Beyfortus marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention," said Iskra Reic, executive vice president of Vaccines and Immune Therapies at AstraZeneca in a statement.
Silke Mader, chairwoman of the executive board and co-founder of the European Foundation for the Care of Newborn Infants (EFCNI), added: "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."
Thomas Triomphe, executive vice president of Vaccines at Sanofi, noted: "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."