Beyfortus Granted Approval in China for Preventing RSV Disease in Infants
Tuesday, January 02, 2024
AstraZeneca and Sanofi have obtained approval from China's National Medical Products Administration (NMPA) for their long-acting monoclonal antibody, Beyfortus (nirsevimab), as a preventive measure against respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants. This approval marks the first preventive option for a broad infant population, including those born healthy at term, preterm, or with specific health conditions making them vulnerable to severe RSV disease. Beyfortus, expected to be available in the 2024-2025 RSV season, demonstrated consistent efficacy in three pivotal late-stage clinical trials, offering protection throughout a typical RSV season.
RSV is a prevalent and highly contagious seasonal virus, causing lower respiratory tract diseases in infants. It is a leading cause of hospitalization in all infants, with China experiencing a high prevalence of RSV infections. Beyfortus aims to alleviate the disease burden on children and families, providing a crucial contribution to the prevention and control of RSV disease in China.
Professor Liu Hanmin, President of West China Second University Hospital, emphasized the importance of prevention due to the lack of specific treatment for RSV disease in infants. Beyfortus, as an innovative long-acting monoclonal antibody, offers protection with a single dose, potentially reducing the pressure on the medical system caused by pediatric respiratory diseases.
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies at AstraZeneca, highlighted Beyfortus as the first opportunity to prevent serious respiratory disease due to RSV for all infants in China. The approval in China follows previous approvals in the European Union and the United States, with regulatory applications under review in Japan and other countries.
RSV is a significant viral pathogen causing acute respiratory infections in children under five years old, particularly impacting infants under one year old. Severe RSV infections can lead to long-term consequences such as recurrent wheezing or asthma, emphasizing the importance of preventive measures.
Beyfortus, developed using AstraZeneca's YTE technology, is a single-dose long-acting antibody providing rapid protection against RSV without activating the immune system. The approval in China is based on the positive results from global pivotal clinical trials, demonstrating its efficacy in protecting infants during their first RSV season. The regulatory designations granted to Beyfortus aim to expedite its development and availability to address the needs of vulnerable populations worldwide.
Source: astrazeneca.com
