AstraZeneca and Sanofi’s Beyfortus approved in China
Betsy Goodfellow | January 2, 2024 | News story | Research and Development | AstraZeneca, Beyfortus, China, Immunology, Sanofi
AstraZeneca and Sanofi have announced that Beyfortus (nirsevimab) has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection and disease (LRTI and LRTD) in neonates and infants entering or during their first RSV season.
Beyfortus is now expected to become available during the 2024-2025 RSV season, and is the first preventative option available to protect against RSV in a broad infant population including those born healthy at term, preterm or with specific health conditions making them vulnerable to RSV disease.
The National Medical Products Administration’s (NMPA) approval follows results from three pivotal late stage clinical trials and an extensive local clinical development programme. One dose of the drug demonstrated a consistent level of efficacy against RSV LRTD for at least five months, the typical length of an RSV season.
Professor Liu Hanmin, president of West China Second University Hospital, Sichuan University, China, commented: “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.”
Betsy Goodfellow
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