France-based Sanofi (NASDAQ: SNY) has announced that it, along with AstraZeneca (AZ; NASDAQ: AZN), has received marketing approval from the US Food and Drug Administration (FDA) for their codeveloped drug, Beyfortus (nirsevimab). The drug is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in infants who are at risk. This decision comes under breakthrough therapy designation (BTD) status and is supported by Phase II/III data demonstrating that the long-acting biologic reduced the incidence of RSV LRTD by 70.1% and hospitalization by 78.4% compared to placebo.
Launch Plans for the Upcoming RSV Season
The partners are now preparing to launch Beyfortus in the US market in time for the 2023-2024 RSV season. This timely approval and launch plan underscore the importance of the drug in addressing the health risks associated with RSV infection in infants, particularly those with predisposing conditions that make them more vulnerable to severe RSV LRTD.-Fineline Info & Tech
