London – AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.1 Beyfortus is anticipated to be available during the upcoming 2024-2025 RSV season.
Beyfortus is the first approved preventive option to protect against RSV in a broad infant population, including protecting those infants born healthy at term, or preterm, or with specific health conditions that make them vulnerable to severe RSV disease. The approval by The National Medical Products Administration (NMPA) is based on three Beyfortus pivotal late-stage clinical trials and an extensive local clinical development programme. Across all clinical endpoints, a single dose of Beyfortus demonstrated consistent efficacy against RSV lower respiratory tract disease (LRTD) extending through five months, the duration of a typical RSV season.2-5
RSV is a common and highly contagious seasonal virus. It is the most common cause of LRTD in infants, including bronchiolitis and pneumonia, and is also a leading cause of hospitalisation in all infants, with most hospitalisations for RSV occurring in healthy infants born at term.6 China ranks among countries with a high prevalence of RSV infections.7
Professor Liu Hanmin, President of West China Second University Hospital, Sichuan University, said: “There is currently no specific treatment for RSV disease in infants, and the potential long-term consequences of severe infections in infancy underscore the importance of prevention. As an innovative long-acting monoclonal antibody, Beyfortus can protect infants across the RSV season with a single dose. Its approval in China has the potential to alleviate the disease burden on children and their families and mitigate pressure on the medical system due to pediatric respiratory diseases. This approval represents a crucial contribution to the prevention and control of RSV disease in China.”
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “Beyfortus represents the first opportunity to prevent serious respiratory disease due to RSV for all infants in China. The science that Beyfortus is built on demonstrates AstraZeneca’s leadership in addressing the needs of the most vulnerable populations and reducing the infectious disease burden on healthcare systems. We look forward to making Beyfortus available for the 2024/5 season.”
Beyfortus was approved in the European Union in October 2022 for the prevention of RSV LRTD in newborns and infants during their first RSV season and received approval by the US Food and Drug Administration in July 2023 following the unanimous recommendation by the Antimicrobial Drugs Advisory Committee in June 2023. Regulatory applications are also currently under review in Japan and several other countries.