Merck Reports the US FDA’s BLA Acceptance of Clesrovimab to Protect Infants from RSV Disease
Shots:
- The US FDA has accepted the BLA of clesrovimab (MK-1654) to protect infants from RSV during their first season, with the decision anticipated on Jun 10, 2025
- BLA was based on pivotal P-IIb/III (CLEVER) study of clesrovimab among healthy preterm & full-term infants (birth – 1yr.) plus P-III (SMART) trial of clesrovimab vs palivizumab in infants & children at increased risk of the disease, with the data highlighted at IDWeek 2024. If approved, clesrovimab could be available by Jul 2025
- Clesrovimab (MK-1654) is a mAb with extended half-life intended for passive immunization in RSV prevention. It provides rapid & durable protection to infants during their first RSV season
Ref: Merck | Image: Merck
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
