Shots:
- The CHMP has recommended Enflonsia to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season, with potential approval valid in all 30 EEA states
- Opinion was 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; data was published in The NEJM
- 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:- Merck Reports P-III (STRIDE-13) Trial of Capvaxive for Active Immunization Against Pneumococcal Disease
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