Novartis Waiting for Regulators Approval to Market Its New Heart Failure Drug in Europe

After receiving the backing of EU regulators, Novartis AG's new heart failure and reduced ejection fraction (HFrEF) drug, Entresto is on track to be approved for use in Europe by the end of the year.

Entresto, also known as LCZ696, is the first new drug in decades for helping patients whose lives are in danger because their hearts cannot pump blood efficiently. Analysts estimate it could have annual sales of some $4.4 billion by 2020.

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"With the poor prognosis heart failure patients face - only half will be alive 5 years from diagnosis - the Committee for Medicinal Products for Human Use (CHMP)endorsement of Entresto brings hope for HFrEF patients in Europe," said David Epstein, Division Head, Novartis Pharmaceuticals. "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."

Basel-based Novartis said it is waiting for final approval from the European Commission before setting a price for the drug.

"Prices in countries in Europe will be confirmed after EC approval and will be determined according to local pricing and reimbursement regulations, submissions and evaluation processes," said Dermot Doherty, Novartis spokesman.

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Entresto won approval in Switzerland last week and got a green light from the U.S. Food and Drug Administration in July.

The CHMP's decision, which follows previous US and Swiss approvals, is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study patients who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.

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"The striking results in the PARADIGM-HF trial led me to believe that once approved LCZ696 could quickly replace what has been the bedrock treatment for more than 20 years, ACE-inhibitors" said Professor John McMurray of the University of Glasgow and one of two Principal Investigators. "Thousands of lives could be extended and hospital admissions prevented with LCZ696's unique ability to boost natriuretic peptides, heart-helpful hormones, while simultaneously inhibiting the RAAS system."

"This is good news," Bank Vontobel analyst Stefan Schneider said in a note to investors. He said it was widely expected by the market after trials that showed the drug cut the risk of death by 20 percent. Schneider anticipates European Commission approval by year-end.

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Novartis is looking to Entresto to help revive its fortunes in heart medicine as the blood pressure pill Diovan - a major source of the company's profits in the past - faces competition from generics.

Source-Medindia