EMA Committee Recommends Approval of Sacubitril/Valsartan (Entresto)

Deborah Brauser


September 25, 2015

LONDON, UK — The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the angiotensin-receptor/neprilysin inhibitor (ARNI) valsartan/sacubitril (Entresto, Novartis) for heart-failure patients[1].

The indication for the ARNI, which is still commonly known as LCZ696, is for HF patients with reduced ejection fraction. The organization noted that the medication should not be taken in conjunction with an angiotensin-receptor blocker (ARB) or an ACE inhibitor.

In addition, because of reports of treatment-related side effects such as hypotension, hyperkalemia, and kidney dysfunction, "CHMP recommended that treatment should not be started in patients with low blood pressure or high potassium levels."

The organization also noted the need for a safety monitoring plan, including for the risk of angioedema.

The CHMP recommendation has now been forwarded to the European Commission, which will decide on EU-wide marketing authorization.

Earlier this summer, the US Food and Drug Administration (FDA) approved this first-in-its-class medication for the treatment of patients with heart failure, based on the PARADIGM-HF trial. The drug consists of the ARB valsartan affixed to the neprilysin inhibitor sacubitril.


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