Novartis Gets Positive CHMP Opinion For Entresto For Pediatric Heart Failure
(RTTNews) - Novartis AG (NVS) announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Entresto (sacubitril/valsartan) for a new indication to treat symptomatic chronic heart failure with left ventricular systolic dysfunction in pediatric patients aged from 1 to <18 years.
The positive opinion is based on final data from the 52-week Phase III PANORAMA-HF trial - the largest pediatric heart failure study ever conducted - and extrapolation of adult heart failure data from the Phase III PARADIGM-HF trial to pediatric patients.
The data showed Entresto provided similar clinically meaningful reductions from baseline in the cardiac biomarker N-terminal pro-B-type natriuretic peptide (NT-proBNP) in adult heart failure patients and pediatric patients aged 1 to <18 years.
Compared to enalapril, the current standard of care in pediatric heart failure, Entresto provided comparable to numerically better improvements from baseline on a number of clinically relevant endpoints.
In this new indication, the CHMP concluded that Entresto brings an important contribution to patient care and therefore fulfills the criteria of significant clinical benefit.
If approved, Entresto will become available to children with a new age-appropriate formulation to enable accurate and convenient administration for these patients and their caregivers. This would support extension of the regulatory data protection to November 2026.
Novartis Lifts FY24 Outlook After Q3 Beats Market; But Stock Down
Novartis Reports Positive Results From Phase III ASC4FIRST Trial; Meets Both Primary Endpoints
Novartis Q1 Profit Tops Market, Lifts FY24 View, Proposes New Chair; Stock Up
Novartis Stock Down As Q4 Core EPS Miss Estimates; Sees Growth In FY24
Novartis Recalls Sandimmune Oral Solution
Novartis Recalls One Lot Of Sandimmune Oral Solution 100 Mg/mL
Novartis Lifts FY23 View As Q2 Results Top Market, Initiates $15 Bln Buyback; Stock Up
