AstraZeneca PLC and Sanofi SA’s long-acting monoclonal antibody Beyfortus received approval for use in China to prevent respiratory syncytial virus disease, Astra said on Tuesday.
The Cambridge, England-based pharmaceutical company said nirsevimab, which goes by the brand name Beyfortus, was approved for the prevention of RSV lower respiratory tract infection in neonates and infants for their first RSV season.
Astra anticipates Beyfortus will be available for the upcoming 2024/25 RSV season.
‘Beyfortus is the first approved preventive option to protect against RSV in a broad infant population, including protecting those infants born healthy at term, or preterm, or with specific health conditions that make them vulnerable to severe RSV disease,’ the company said.
The approval by China’s National Medical Products Administration is based on three ‘pivotal’ late-stage clinical trials and an ‘extensive’ local clinical development programme, Astra said.
Beyfortus was approved for RSV lower respiratory tract disease in the EU in October 2022 and received approval by the US Food & Drug Administration in July 2023. Astra said regulatory applications are currently under review in Japan and ‘several other countries’.
In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize Beyfortus. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities and Sanofi leads commercialization activities and records revenue.
Shares in AstraZeneca were down 0.3% at 10,564.00 pence each in London on Tuesday morning, while Sanofi was up 0.4% to €90.09 in Paris.
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