The U.S. Food and Drug Administration approved AstraZeneca (AZN,AZN.L) and Sanofi’s Beyfortus or nirsevimab for the prevention of respiratory syncytial virus lower respiratory tract disease in infants. The new drug will be available in the US ahead of the upcoming 2023-2024 RSV season, the companies said in a statement.
Beyfortus is the first monoclonal antibody approved to protect all infants through their first RSV season.
Beyfortus has been approved in the US for the prevention of respiratory syncytial virus or RSV lower respiratory tract disease or LRTD 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.
According to the company, the single dose can be flexibly administered at the beginning of the RSV season or at birth for those born during the RSV season.
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.
RSV is a virus that causes acute respiratory infection in individuals of all age groups. While most infants and young children experience mild, cold-like symptoms, some infants, especially with their first infection, develop lower respiratory tract disease such as pneumonia and bronchiolitis (swelling of the small airway passages in the lungs), that often leads to an emergency department or physician office visit.
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