The Committee deems that the clinical benefit of ENTRESTO (sacubitril/valsartan), granules in capsules for opening and film-coated tablets, is substantial for children and adolescents aged one year or overolder for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction.
Clinical Added Value
minor
In view of:
the extrapolation deemed to be valid of the efficacy data of the sacubitril/valsartan combination to children based on the results of the PARADIGM-HF study in adults which provided evidence of a reduction in cardiovascular morbidity-mortality;
an insufficiently met medical need with therapeutic alternatives having a low level of evidence in children and with pharmaceutical forms not suited to paediatrics;
the provision of a pharmaceutical form of the sacubitril/valsartan combination suitable for children aged from 1 year;
an acceptable safety profile in children, which is comparable to that already known in adults;
but in the light of:
the lack of evidence of superiority of the sacubitril/valsartan combination in relation to enalapril on clinical morbidity-mortality outcome measures in the PANORAMA-HF paediatric study, with however results deemed clinically relevant in both treatment groups based on experts opinion;
suboptimal representativeness of the studied population in the PANORAMA-HF study with a small sample of children aged under 1 year (population excluded from the marketing authorisation), the exclusion of the perioperative period (pre-heart surgery, pre-heart transplantation and immediate postoperative period) and the exclusion of congenital hypertrophic and restrictive cardiomyopathies which are rare but largely relevant to paediatric heart failure;
the Committee deems that ENTRESTO (sacubitril/valsartan), granules in capsules for opening at the dosages of 6 mg/6 mg and 15 mg/16 mg and film-coated tablets at the dosages of 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg,provides minor clinical added value (CAV IV) in the current therapeutic strategy in respect of symptomatic chronic heart failure with left ventricular systolic dysfunction in children and adolescents aged one year or overolder.
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