Beyfortus Approved in Japan for RSV Prevention in Infants
AstraZeneca and Sanofi's Beyfortus has received approval in Japan for the prevention of respiratory syncytial virus (RSV) disease in neonates and infants. It is expected to be available for the upcoming season.
Tokyo – AstraZeneca and Sanofi announced that Beyfortus (nirsevimab) has been approved in Japan for the prophylaxis of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in neonates and infants. The approval covers all neonates, infants, and children entering their first RSV season, as well as those at risk of serious RSV infection entering their first or second season.
Beyfortus is a long-acting monoclonal antibody and represents the first preventive option developed to protect a broad infant population against RSV LRTD. The approval by Japan's Ministry of Health, Labour and Welfare is based on three clinical trials where a single dose of Beyfortus demonstrated consistent efficacy against RSV LRTD for up to five months, covering a typical RSV season.
Over 100,000 cases of RSV LRTD in infants are reported annually in Japan, including healthy, full-term newborns. RSV affects nearly all children by the age of two and can lead to significant disease burden and long-term consequences.
Beyfortus is anticipated to be available in Japan for the 2024–2025 RSV season. The drug has previously received approval in the European Union, the United States, and China.