Swissmedic Approves Novartis’ Entresto for Treatment of Heart Failure
Swiss health authority Swissmedic has approved Novartis’ Entresto, enabling other health authorities to complete their reviews of the heart failure drug.
Entresto (sacubitril/valsartan) is indicated in Switzerland to reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction.
The approval is based on results of an 8,442-patient study showing Entresto significantly reduced the risk of cardiovascular death versus angiotensin-converting enzyme inhibitor enalapril.
Entresto is administered in combination with other appropriate heart failure therapies in place of an ACE inhibitor or angiotensin receptor blocker.
The drug will be available on prescription for adult patients whose condition is classified NYHA class II-IV and with an ejection fraction of 40 percent or less, Novartis says.
The decision by Swissmedic, announced last week, follows the FDA’s approval in July. — Jonathon Shacat