Sanofi Korea is set to launch Beyfortus (nirsevimab) early next year, an RSV preventive antibody injection approved by the Ministry of Food and Drug Safety in April. This announcement was made during a press conference held on Tuesday, highlighting the drug's potential to protect infants and young children from respiratory syncytial virus (RSV).
Professor Yoon Ki-wook of Seoul National University Hospital’s Department of Pediatric Infectious Diseases emphasized the critical need for RSV prevention in infants, noting that 90% of children under two years old contract RSV. The infection can lead to severe conditions such as bronchiolitis or pneumonia, often requiring hospitalization. He pointed out that, "Among infants hospitalized for RSV-related infections during their first RSV season, 78 percent were full-term and otherwise healthy, underscoring the need for prevention options for all infants."
Clinical Efficacy and Safety
Beyfortus is designed for newborns and infants in their first RSV season, as well as children under 24 months at high risk of severe RSV during their second season. The MELODY phase 3 trial, which included 3,012 infants entering their first RSV season, demonstrated a 74.5% reduction in RSV-related lower respiratory tract infections requiring medical attention. These findings underscore the potential of Beyfortus to significantly reduce the burden of RSV-related illnesses in infants.
Real-World Evidence
Real-world data from Galicia, Spain, where Beyfortus was integrated into the regional immunization program, showed an impressive 82% reduction in RSV-related hospitalizations among infants under six months. Additional support for Beyfortus’s efficacy comes from a U.S. Centers for Disease Control and Prevention (CDC) study during the 2023-2024 RSV season, which found the injection to be 90% effective in preventing RSV-related hospitalizations among 699 infants.
Addressing Unmet Needs
Sanofi Korea emphasized that Beyfortus addresses a significant unmet need by providing a proactive RSV prevention option for all infants. This marks a crucial step in alleviating the healthcare and socioeconomic burdens associated with RSV, offering a targeted approach to protect vulnerable infants from severe respiratory infections.
