China Approves AstraZeneca-Sanofi's Respiratory Syncytial Virus Drug To Prevent Infection In Infants

Tuesday, China's National Medical Products Administration approved AstraZeneca Plc AZN and Sanofi SA's SNY Beyfortus (nirsevimab), a long-acting monoclonal antibody for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.

Beyfortus will be available during the 2024-2025 RSV season.

Beyfortus is the first approved preventive option to protect against RSV in a broad infant population, including protecting those infants born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease. 

The approval is based on three Beyfortus pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of Beyfortus demonstrated consistent efficacy against RSV lower respiratory tract disease (LRTD), extending through five months, the duration of a typical RSV season.

Beyfortus was approved in the European Union in October 2022 for the prevention of RSV LRTD in newborns and infants during their first RSV season and received approval by the FDA in July 2023 following the unanimous recommendation by the Antimicrobial Drugs Advisory Committee in June 2023. 

In November, the U.S. Centers for Disease Control and Prevention (CDC) released more than 77,000 additional doses of Beyfortus (nirsevimab), a respiratory syncytial virus drug.

Price Action: AZN shares are down 0.85 at $66.77 during the premarket session on the last check Tuesday, and SNY stock closed at $49.73 on Friday.