FDA
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Today the FDA announced its approval of AstraZeneca’s monoclonal antibody, Beyfortus (nirsevimab-alip), for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering or during their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
“RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families, and the health care system.”
According to the press release, RSV is an often severe virus that causes respiratory infection in individuals of all ages. Infants and young children can develop severe lower respiratory tract diseases like pneumonia and bronchiolitis. Other patients are at higher risk, especially premature infants, those with chronic lung disease of prematurity or congenital heart disease, and older patients. According to the American Academy of Pediatrics, RSV hospitalizes approximately 1% to 3% of children under 12 months of age in the United States annually.
As a monoclonal antibody with activity against RSV, it is a “laboratory-made protein that mimics the immune system’s ability to fight off harmful pathogens such as viruses. One dose of Beyfortus, administered as a single intramuscular injection before or during RSV season, may protect during the RSV season,” according to the press release.
“RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families, and the health care system.”
Three clinical trials (Trials 03, 04, and 05) supported the efficacy and safety of Beyfortus. Trial 03 enrolled 1,453 preterm infants born between 29 and 35 weeks of gestational age during their first RSV season. Beyfortus reduced medically attended RSV lower respiratory tract infection (MA RSV LRTI) risk by approximately 70% compared to the placebo. Trial 04 included 1,490 babies born at 35+ weeks. Of those included, 994 infants received Beyfortus, and 496 received a placebo. Beyfortus reduced the risk of MA RSV LRTI by approximately 75% compared to the placebo. Trial 05 tested Beyfortus on 925 at-risk infants up to 24 months old. The results showed it can prevent MA RSV LRTI in this population. The trial was a “randomized, double-blind, active (palivizumab)-controlled, multicenter trial, [that] supported the use of Beyfortus in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season,” according to the press release.
Beyfortus may cause rash and reactions at the injection site. It is important to note that infants and children who have experienced severe hypersensitivity reactions to the active ingredients or excipients in Beyfortus should avoid taking this medication.
The press release noted that the Beyfortus received a Fast Track designation for this indication.