Sanofi announced it has begun shipping doses of Beyfortus (nirsevimab-alip) in the U.S., for newborns and infants against respiratory syncytial virus (RSV).
The company is supplying doses to private healthcare providers and the Centers for Disease Control and Prevention's Vaccines for Children program to ensure availability before the upcoming RSV season. Beyfortus is a long-acting monoclonal antibody that has been approved by the FDA for the prevention of RSV-related lower respiratory tract disease in newborns and infants.
To meet growing demand, Sanofi has now expanded its manufacturing capacity by launching a new filling line, which recently received FDA approval. This new production line, developed in collaboration with AstraZeneca, will help ensure sufficient supply for the U.S. market during the 2024/2025 RSV season. Sanofi has also implemented a reservation program for healthcare providers to prioritize fulfillment of Beyfortus requests as part of their effort to ensure equitable access.
RSV is a leading cause of severe respiratory illness in infants, with two out of three babies infected during their first year of life. The virus can lead to complications such as bronchiolitis and pneumonia, especially in vulnerable infants.
Beyfortus was first approved by the FDA in July of last year, for the prevention of RSV lower respiratory tract disease in newborns and infants, making it the first RSV preventive option approved in the U.S. for a broad infant population. The approval followed a unanimous 21 to 0 vote by the Antimicrobial Drugs Advisory Committee for its use in infants, and 19 to 2 for children up to 24 months.