FDA approves respiratory syncytial virus drug for children up to 24 months of age

FDA

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Today, the FDA announced approval of AstraZeneca’s monoclonal antibody, Bayfortas (nilsevimab-Alip), for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants before or during their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease until their second RSV season.

“RSV can cause serious illness in infants and some children, resulting in a large number of emergency department and physician visits each year,” said John Farley, M.D., MPH, director of the FDA’s Center for Drug Evaluation and Research’s Office of Infectious Diseases. “Today’s approval addresses a significant need for products to reduce the impact of RSV infection on children, families and the healthcare system.”

according to press release, RSV is a serious virus that causes respiratory infections in people of all ages. Infants and young children can develop severe lower respiratory tract diseases such as pneumonia and bronchiolitis. Others are at increased risk, especially premature infants, those with chronic lung disease due to prematurity or congenital heart disease, and older patients. According to the American Academy of Pediatrics, about 1% to 3% of children under 12 months of age are hospitalized with her RSV each year in the United States.

As a monoclonal antibody with activity against RSV, it is “a lab-made protein that mimics the immune system’s ability to fight harmful pathogens such as viruses.” A single intramuscular injection of Bayfortus before or during the RSV season may provide protection during the RSV season, according to a press release.

“RSV can cause serious illness in infants and some children, resulting in a large number of emergency department and physician visits each year,” said John Farley, M.D., MPH, director of the FDA’s Center for Drug Evaluation and Research’s Office of Infectious Diseases. “Today’s approval addresses a significant need for products to reduce the impact of RSV infection on children, families and the healthcare system.”

Three clinical trials (Studies 03, 04, and 05) supported the efficacy and safety of Bayfortus. trial 03 enrolled 1,453 preterm infants born between 29 and 35 weeks gestational age during the first RSV season. Bayfortus reduced the risk of hospital-acquired RSV lower respiratory tract infections (MA RSV LRTI) by approximately 70% compared to placebo. trial In 2004, 1,490 babies born at 35 weeks or older were included. Of these, 994 infants received Beyfortas and 496 received placebo. Beyfortus reduced the risk of MA RSV LRTI by approximately 75% compared to placebo. trial 05 Researchers tested Bayfortus in 925 at-risk infants up to 24 months of age. Results showed that MA RSV LRTI could be prevented in this population. The study was a “randomized, double-blind, active (palivizumab)-controlled, multicenter trial.” [that] “By the second season of RSV, we have endorsed the use of Bayfortus in children up to 24 months of age who are susceptible to severe RSV disease,” according to a press release.

Bay Fortus can cause a rash or reaction at the injection site. It is important to note that infants and children who have experienced severe hypersensitivity reactions to Beyfortas active ingredients or excipients should avoid taking this medication.

In a press release, Bay Fortus fast track Specify this display.

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