China- January 2024- China has approved Beyfortus (nirsevimab), a newly developed long-acting monoclonal antibody from AstraZeneca and Sanofi, to prevent lower respiratory tract infections (LRTIs) caused by the respiratory syncytial virus (RSV) in newborns and infants who are about to enter or are already in their first RSV season. It is anticipated that Beyfortus will be available for the 2024–2025 RSV season.
The National Medical Products Administration (NMPA) granted approval based on three pivotal late-stage clinical trials and an extensive local clinical development program. Beyfortus, the first approved preventive option for a broad infant population, has shown consistent efficacy against RSV lower respiratory tract disease (LRTD) for five months with a single dose, covering the typical RSV season.
However, RSV is a common, highly contagious seasonal virus, and is the major cause of LRTD in infants, including bronchiolitis and pneumonia. Also, It is a leading cause of hospitalization in all infants, with China ranking among countries with a high prevalence of RSV infections.
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 behind Beyfortus demonstrates AstraZeneca’s leadership. It addresses the needs of the most vulnerable populations, reducing the infectious disease burden on healthcare systems. We look forward to making Beyfortus available for the 2024/5 season.”
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Moreover, The European Union approved Beyfortus in October 2022, followed by the US Food and Drug Administration’s approval in July 2023. Regulatory applications are under review in Japan and other countries, reinforcing its potential as a significant advancement in RSV prevention.
