EMA's CHMP backs Novartis heart failure drug Entresto for EU approval

25 September 2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Swiss pharma giant Novartis’ (NOVN: VX) Entresto (sacubitril/valsartan), marking an important milestone towards becoming available in the European Union.

Pending final approval by the European Commission Entresto, previously known as LCZ696, will be available for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF). Novartis’s shares gained 4.2% to 92.10 Swiss francs in late morning trading today.

"With the poor prognosis heart failure patients face - only half will be alive five years from diagnosis - the CHMP's endorsement of Entresto brings hope for HFrEF patients in Europe," said David Epstein, division head, Novartis Pharmaceuticals, adding: "Already we're hearing about the benefits US doctors and HFrEF patients are experiencing with Entresto and hope to receive a final green-light from the EC soon."

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