AstraZeneca-Sanofi's Respiratory Syncytial Virus Treatment Scores FDA Approval To Prevent Infection In Infants

The FDA approved AstraZeneca Plc AZN and Sanofi SA’s SNY Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants.

The approval covers newborns and infants during or entering their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Beyfortus was approved in the European Union in November 2022 to prevent RSV LRTD in newborns and infants during their first RSV season.

Regulatory applications are also under review in China, Japan, and several other countries.

Beyfortus will be available in the US before the 2023-2024 RSV season.

The FDA approval followed the unanimous vote by the Antimicrobial Drugs Advisory Committee (AMDAC) on the favorable benefit-risk profile of Beyfortus. 

Across all clinical endpoints, a single dose of Beyfortus demonstrated consistent efficacy against RSV LRTD, extending through five months, the duration of a typical RSV season.

Beyfortus is the first preventive option approved to protect a broad infant population. 

The single dose can be flexibly administered at the beginning of the RSV season or birth for those born during the RSV season.

RSV is the leading cause of hospitalization for infants under one in the U.S., averaging 16 times higher than the annual rate for influenza. Annually, an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits, and hospitalizations.

Price Action: AZN shares are down 0.15% at $66.95 and SNY shares are up 1.06% at $53.45 during the premarket session on the last check Tuesday.