Novartis' new heart failure medicine Entresto gets Swissmedic thumbs up

Switzerland-based pharma giant Novartis (NOVN: VX) announced today that Swissmedic has approved Entresto (sacubitril/valsartan), previously known as LCZ696, to reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction (HFrEF).

Entresto will be available on prescription for adult patients whose condition is classified NYHA class II-IV and with an ejection fraction of 40% or less. It is administered in combination with other heart failure therapies as appropriate, in place of an ACE inhibitor or angiotensin receptor blocker.

This is the second regulatory approval for Entresto, which was recently cleared by the US Food and Drug Administration, some six weeks ahead of the FDA’s priority review date (The Pharma Letter July 8). It was the second new heart failure approved by the FDA in recent months, the first being US biotech major Amgen’s (Nasdaq: AMGN) Corlanor (ivabradine).