The US Food and Drug Administration (FDA) has approved AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season.
The drug is also approved in 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, 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.”
Premature infants, and those with chronic lung disease of prematurity or significant congenital heart disease, are at highest risk for severe RSV disease.
The application was supported by three clinical trials (Trials 03, 04 and 05). The key measure of efficacy was the incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI).
Trial 03 included 1,453 preterm infants who were born during or entering their first RSV season. Beyfortus reduced the risk of MA RSV LRTI by approximately 70% relative to placebo. For Trial 04, the primary analysis group within the trial included 1,490 term and late preterm infants. Beyfortus reduced the risk of MA RSV LRTI by approximately 75% relative to placebo.
Trial 05 supported the use of Beyfortus in in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.