Clesrovimab FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 21, 2025.
FDA Approved: No
Generic name: clesrovimab
Company: Merck
Treatment for: RSV
Clesrovimab is an extended half-life monoclonal antibody in development as a passive immunization for the prevention of respiratory syncytial virus (RSV) disease in infants.
- RSV is a contagious virus that causes widespread seasonal infections and can lead to serious respiratory conditions such as bronchiolitis and pneumonia in infants.
- Clesrovimab (MK-1654) is a monoclonal antibody designed to be administered at the same single dose (regardless of weight) to infants to provide direct, rapid, and durable protection against mild, moderate and severe RSV through their first RSV season.
- The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab to protect infants from RSV disease during their first RSV season. The application is supported by results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004), a randomized placebo-controlled trial evaluating a single dose of clesrovimab administered to healthy preterm and full-term infants (birth to 1 year of age), and interim results from the ongoing Phase 3 SMART trial (MK-1654-007) evaluating the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease.
- The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 10, 2025.
Development timeline for clesrovimab
Further information
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