Novartis Receives EMA’s CHMP Positive Opinion of Entresto (sacubitril/valsartan) for Heart Failure in Pediatric Patients
- The EMA’s CHMP has adopted a positive opinion recommending approval of Entresto to treat symptomatic chronic HF with LV systolic dysfunction in pediatric patients aged 1-<18yrs.
- The opinion was based on the 52wk. results from the P-III trials (PANORAMA-HF) & (PARADIGM-HF) showed similar reductions from baseline in the cardiac biomarker NT-proBNP in adult & pediatric patients, numerically better improvements from baseline on a no. of clinically relevant EPs over enalapril
- The safety & tolerability were consistent with that observed in adult patients. If Entresto is approved, it will become available to children with a new age-appropriate formulation to enable accurate & convenient administration
Ref: Novartis | Image: Novartis
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