Novartis Receives EMA’s CHMP Positive Opinion of Entresto (sacubitril/valsartan) for Heart Failure in Pediatric Patients
Shots:
- 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
Related News:- Novartis's Entresto Receives US FDA's Approval for Chronic Heart Failure
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
