FDA approves RSV drug for children up to 24 months

FDA

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Today, the FDA announced its approval of AstraZeneca’s monoclonal antibody, Beyfortus (nirsevimab-alip), for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. infants entering or during their first RSV season and children up to 24 months who remain vulnerable to severe RSV infection during their second RSV season.

“RSV can cause serious illness in infants and some children and results in a large number of emergency room and doctor’s office visits each year,” said John Farley, MD, MPH, director of the Center’s Office of Infectious Diseases. FDA Drug Review. and Research. “Today’s approval responds to the great need for products to help reduce the impact of RSV disease on children, families and the healthcare system.”

According to Press release, RSV is an often serious virus that causes respiratory infection in people of all ages. Infants and young children can develop serious lower respiratory illnesses such as pneumonia and bronchiolitis. Other patients are at higher risk, especially premature babies, people 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 younger than 12 months in the United States each year.

As a monoclonal antibody with activity against RSV, it is a “laboratory-made protein that mimics the ability of the immune system to fight off harmful pathogens such as viruses. A dose of Beyfortus, given as a single intramuscular injection before or during RSV season, may protect during RSV season,” according to the press release.

“RSV can cause serious illness in infants and some children and results in a large number of emergency room and doctor’s office visits each year,” said John Farley, MD, MPH, director of the Center’s Office of Infectious Diseases. FDA Drug Review. and Research. “Today’s approval responds to the great need for products to help reduce the impact of RSV disease on children, families and the healthcare system.”

Three clinical trials (Trials 03, 04 and 05) confirmed the efficacy and safety of Beyfortus. Trial 03 enrolled 1453 preterm infants born between 29 and 35 weeks gestational age during their first RSV season. Beyfortus reduced the risk of clinically assisted RSV lower respiratory tract infection (MA RSV LRTI) by approximately 70% compared to placebo. Trial 04 included 1,490 babies born at over 35 weeks. Of those included, 994 infants received Beyfortus and 496 received a placebo. Beyfortus reduced the risk of AM RSV LRTI by approximately 75% compared to placebo. Trial 05 tested Beyfortus on 925 at-risk infants up to 24 months of age. The results showed that it can prevent MA RSV LRTI in this population. The trial was a “multicenter, randomized, double-blind, active treatment (palivizumab) controlled trial, [that] supported the use of Beyfortus in children up to 24 months of age who remain vulnerable to severe RSV infection through their second RSV season,” according to the press release.

Beyfortus can cause skin rashes and reactions at the injection site. It is important to note that infants and children who have shown severe hypersensitivity reactions to the active substances or excipients of Beyfortus should avoid taking this medicine.

The press release noted that the Beyfortus received a Expressway designation for this indication.