The explanation given was that “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 proBNP (NT-proBNP) in pediatric patients 1 to <18 years with HF due to systemic LV systolic dysfunction with sacubitril/valsartan. This evidence concerns the gene NPPB and hydrops fetalis.