The first new medicine for heart failure in 10 years could be at pharmacies by mid-2015 and its encouraging clinical trial results are cause for elation among cardiologists.

The drug still known as LCZ696 works at the hormonal level to dilate vessels and helps patients remove more fluid. A product of Swiss pharmaceutical firm, Novartis, LCZ696 is an investigational medicine for patients with heart failure with reduced ejection fraction (HFrEF).

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Experts said some 50 percent of heart failure patients or those with a weakened pumping ability could benefit from LCZ696.

Clinical trial results were so encouraging LCZ696 was recently granted accelerated assessment the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

In the United States, LCZ696 was granted Fast Track designation by the U.S. Food and Drug Administration and a rolling submission is expected to be complete by the end of 2014.

Novartis will submit the file for marketing authorization in the European Union in early 2015.

The submission will be based on results from the landmark PARADIGM-HF study that showed LCZ696 was superior to ACE-inhibitor enalapril on key endpoints. These included significantly reducing the risk of cardiovascular death or heart failure hospitalization.

New analyses presented earlier this month shows LCZ696 significantly reduced the risk of dying suddenly by 20 percent; reduced first and subsequent HFrEF hospitalizations by 21 percent and 23 percent, respectively; reduced hospitalizations for a CV reason or for any reason both by 16 percent. 

"Since 2004 we didn't have any new medications for heart failure. So we're very excited," said Dr Nir Uriel, University of Chicago cardiologist.

"This medication was studied in almost 10,000 patients and was shown to be superior to the current therapy that we were using. The investigational drug was shown to reduce mortality and hospital readmissions by 20 percent", he added.

He noted the holy grail of heart failure is to reverse what is going on in the heart and try to get some regeneration and make the heart stronger.

"Sometimes, by letting the heart work less it will become stronger".

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