FDA approves Beyfortus to protect infants against RSV disease
Sanofi and AstraZeneca have received the Food and Drug Administration’s permission for Beyfortus (nirsevimab-alip) 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. The companies said they plan to make Beyfortus available in the United States ahead of the upcoming 2023-2024 RSV season.
RSV is the leading cause of hospitalization for infants under the age of one in the United States, averaging 16 times higher than the annual rate for influenza. Each year, an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations, the companies noted
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“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. healthcare system,” said Thomas Triomphe, executive vice president of vaccines at Sanofi. Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season. I am proud that, by prioritizing this potential game-changer, we are now about to bring Beyfortus to American families.”
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“Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the United States. 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,” said Iskra Reic, executive vice president of vaccines and immune therapies at AstraZeneca.