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(Alliance News) - AstraZeneca PLC and Sanofi SA on Monday said the US Food & Drug Administration has approved the use of Beyfortus, or nirsevimab, in the US.
AstraZeneca is a Cambridge, England-based pharmaceutical firm. Sanofi is a Paris-based pharmaceutical firm.
AstraZeneca and Sanofi's Beyfortus has been approved in the US for the prevention of respiratory syncytial virus lower respiratory tract disease in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
RSV is a contagious virus that causes respiratory illness in infants, including lung infections such as bronchiolitis and pneumonia.
"Beyfortus is the first preventive option approved to protect a broad infant population, including those born healthy at term, or preterm, or with specific health conditions that make them vulnerable to severe RSV disease. The single dose can be flexibly administered at the beginning of the RSV season or at birth for those born during the RSV season," AstraZeneca explained.
It added that approval by the FDA follows the unanimous vote by the Antimicrobial Drugs Advisory Committee on the favourable benefit-risk profile of Beyfortus, and was based on the extensive clinical development programme for Beyfortusspanning three pivotal late-stage clinical trials.
Iskra Reic, executive vice president of Vaccines & Immune Therapies at AstraZeneca, said: "Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the US. The science that Beyfortus is built on demonstrates AstraZeneca's continued leadership in addressing the needs of the most vulnerable populations and reducing the burden on healthcare systems."
Beyfortus was approved in the European Union in October 2022 for the prevention of RSV LRTD in newborns and infants during their first RSV season. Regulatory applications are also currently under review in China, Japan and "several other countries."
By Sophie Rose, Alliance News reporter
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