Sanofi announced Quebec's National Institute of Excellence in Health and Social Services (INESSS) recommends BEYFORTUS® to be used for the prevention of RSV lower respiratory tract disease (LRTD) in all neonates and infants aged 8 months and younger. Furthermore, the INESSS Standing Committee on Deliberation ? Reimbursement and Access unanimously agree that BEYFORTUS® provides significant clinical benefits compared to placebo in reducing lower respiratory tract infections that require medical assistance as well as hospitalization due to RSV infection, in the healthy, full-term, or premature pediatric population during the first RSV season. The Committee also recognizes the therapeutic value of BEYFORTUS® in the population for whom the risk of developing a serious infection persists for a second RSV season.

Health Canada issued a Notice of Compliance for BEYFORTUS® in April 2023. Additionally, it was approved by the FDA in the United States in July 2023, the European Union in October 2022 and in Great Britain in November 2022. Regulatory applications are also currently under review in several other countries.

Sanofi is working with Quebec provincial authorities to make BEYFORTUS® available to a broad cohort of infants for the 2024-25 RSV season.