Shots:
- The EC has approved Enflonsia (clesrovimab) to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk infants
- The Phase 2b/3 CLEVER trial (N=3,614) evaluated in infants entering their first RSV season. Enflonsia reduced RSV-associated medically attended LRIs by 60.4% and hospitalizations by 84.2% vs PBO through 5 mos. It also reduced severe RSV MALRI by 91.7% and RSV-associated LRI hospitalizations by 90.9%, meeting 1EP and 2EPs. Data from the CLEVER and SMART trials were published in The NEJM in Sept. 2025
- Enflonsia (105mg/0.7 mL, PFS) is a long-acting preventive monoclonal antibody designed to deliver immediate & sustained protection for up to 5mos., with a single weight-independent dose
Ref: Merck | Image: Merck | Press Release
Related News:- The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
