AstraZeneca and Sanofi’s nirsevimab, commercially known as Beyfortus, has gained approval in China for averting lower respiratory tract infections (LRTIs) caused by respiratory syncytial virus (RSV) in neonates and infants during their first RSV season. The approval by China’s National Medical Products Administration (NMPA) marks a significant advancement in protecting infants against severe respiratory syncytial virus disease. Beyfortus is anticipated to be accessible in the upcoming 2024-2025 respiratory syncytial virus season.
This milestone authorization encompasses a broad infant population, encompassing healthy term infants, preterm infants, and those with specific health conditions that make them prone to severe RSV disease. The endorsement from NMPA is founded on robust evidence from three pivotal late-stage clinical trials and a comprehensive local clinical development program. The trials showcased the consistent efficacy of Beyfortus, demonstrating protection against RSV LRTD for up to five months, coinciding with the typical RSV season duration.
Beyfortus’ Efficacy Across Infant Populations for Respiratory Syncytial Virus Prevention
RSV stands as a prevalent and contagious seasonal virus, primarily responsible for lower respiratory tract diseases like bronchiolitis and pneumonia in infants. It also contributes significantly to hospitalizations, especially among healthy-term infants. China, in particular, contends with a high incidence of RSV infections.
Professor Liu Hanmin, President of West China Second University Hospital, Sichuan University, highlighted the critical significance of prevention in the absence of specific treatments for RSV disease in infants. Beyfortus’s approval presents a vital opportunity to mitigate disease burdens on families, alleviate pressure on the healthcare system, and prevent severe infections among infants.
AstraZeneca’s Commitment to Combat RSV-related Diseases
Iskra Reic, Executive Vice President of Vaccines and Immune Therapies at AstraZeneca, underscored Beyfortus’s role in preventing severe respiratory diseases attributed to RSV in China. The approval reflects AstraZeneca’s commitment to addressing vulnerable populations’ needs and reducing the burden of infectious diseases on healthcare systems.
Previously approved in the European Union and the United States, Beyfortus is awaiting regulatory decisions in Japan and other nations, further signifying its global significance in preventing severe RSV-related diseases in infants.
Resource: AstraZeneca, January 02, 2023
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