EMA Advisory Committee Recommends Novartis’ New Drug for Chronic Heart Failure
The Committee for Medicinal Products for Human Use of the European Union has adopted a positive opinion for Entresto( (sacubitril/valsartan), a new drug to treat chronic heart failure. Pending final approval by the European Commission, Entresto will be available for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction. The drug was approved by the US Food and Drug Administration in July 2015.
Novartis has high hopes for Entresto. A recent Thomson Reuters analysis estimates 2019 sales for Entresto at $3.7 billion, and Novartis estimates possible peak sales in excess of $5 billion for the reduced ejection fraction indication on a global basis.
Entresto is an angiotensin receptor neprilysin inhibitor that reduces the strain on the failing heart. A twice-a-day tablet, it acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system, the renin-angiotensin-aldosterone system (RAAS).