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AstraZeneca's Beyfortus gets approval in Japan for RSV prevention

EditorEmilio Ghigini
Published 03/27/2024, 09:24 AM
© Reuters

TOKYO - AstraZeneca (NASDAQ:AZN), in partnership with Sanofi (NASDAQ:SNY), has announced that its long-acting monoclonal antibody, Beyfortus (nirsevimab), has received approval from the Japanese Ministry of Health, Labour and Welfare for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in a broad infant population.

Beyfortus is now authorized for prophylaxis in all neonates and infants entering their first RSV season and for those at risk of serious RSV infection entering their first or second season.

The newly approved treatment is the first to offer RSV disease prevention for such a wide range of infants, including those born at term, preterm, or with certain health conditions that increase vulnerability to severe disease. Beyfortus is expected to be available for the 2024/25 RSV season, aligning with Japanese health guidelines.

The approval is supported by evidence from three pivotal late-stage clinical trials, which demonstrated that a single dose of Beyfortus provided consistent protection against RSV LRTD over a five-month period, typically covering the duration of an RSV season. In Japan, over 100,000 cases of RSV LRTD are reported annually among infants, including those born healthy and at term.

Dr. Hiroyuki Moriuchi, a leading pediatrician at Nagasaki University, hailed the approval as a significant step in combating RSV in infants, a common and burdensome illness that can lead to long-term health issues. Iskra Reic, Executive Vice President at AstraZeneca, emphasized the potential of Beyfortus to alleviate the healthcare burden by preventing serious respiratory diseases in all infants in Japan.

Beyfortus has previously been approved in the European Union, United States, and China. This approval marks a continuation of AstraZeneca's commitment to developing preventive healthcare solutions for vulnerable patient groups.

The approval criteria for Beyfortus in Japan cover neonates, infants, and children at risk of severe RSV infection, including those born prematurely or with specific health conditions such as chronic lung disease, significant congenital heart disease, immunocompromised conditions, or Down syndrome.

AstraZeneca and Sanofi will co-promote Beyfortus in Japan, reflecting the companies' collaborative efforts in the development and commercialization of the treatment. This announcement is based on a press release statement.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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