Merck Secures U.S. Approval for ENFLONSIA Targeting Infant RSV
Tuesday, June 10, 2025
Merck has received approval from the U.S. Food and Drug Administration (FDA) for ENFLONSIA™ (clesrovimab-cfor).
ENFLONSIA is a long-acting monoclonal antibody (mAb) developed to offer direct and lasting protection for up to five months, which typically covers the length of the RSV season, running from autumn to spring. The treatment is given as a single fixed dose of 105 mg, with no need to adjust based on the infant’s weight.
RSV is one of the leading causes of hospital admission in infants in the United States, often leading to complications such as bronchiolitis and pneumonia. ENFLONSIA has been developed as a convenient option to help reduce the risk of severe disease in early life.
This medicine is authorised for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are either born during or entering their first RSV season.
The product is expected to be available in the United States before the start of the 2025–2026 RSV season, with ordering anticipated to begin in July 2025.
The Advisory Committee on Immunization Practices (ACIP) in the United States is expected to review and provide recommendations on its use in infants later this month.
Source: merck.com
