Posted by Michael Wonder on 03 Oct 2019
Novartis Entresto receives FDA approval for paediatric heart failure, helping to address critical unmet need for treatment options
1 October 2019 - Entresto is now approved for the treatment of paediatric patients aged 1 year and older with symptomatic heart failure with systemic left ventricular systolic dysfunction.
Novartis announced today that the U.S. FDA has approved Entresto (sacubitril/valsartan) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged 1 year and older. Entresto reduces NT-proBNP and is expected to improve cardiovascular outcomes.
The approval was based on an analysis at 12 weeks from the 52-week PANORAMA-HF trial which demonstrated reductions in the cardiac biomarker N-terminal pro-B-type natriuretic peptide in paediatric patients 1 to <18 years with heart failure due to systemic left ventricular systolic dysfunction with Entresto.
