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2d ago

FDA Approves Merck’s Enflonsia Monoclonal Antibody for Infant RSV Prevention

Merck plans July shipments of the single-dose antibody ahead of the 2025 RSV season with a CDC advisory review scheduled for late June.

Merck’s ENFLONSIA™ (clesrovimab-cfor) for **HANDOUT**Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season

Overview

  • The FDA approved Merck’s clesrovimab, marketed as Enflonsia, to prevent RSV lower respiratory tract disease in infants during their first RSV season.
  • In the phase II/III CLEVER trial, Enflonsia reduced medically attended RSV lower respiratory infections by 60.4% and RSV-related hospitalizations by 84.2% compared to placebo.
  • Unlike weight-based competitors, Enflonsia uses a single-dose, weight-independent regimen that simplifies dosing in pediatric settings.
  • Priced at $556 per dose to match Sanofi and AstraZeneca’s Beyfortus, Merck aims to begin taking orders in July for delivery before the 2025 season.
  • The CDC’s Advisory Committee on Immunization Practices will review and vote on official recommendations for Enflonsia in late June.