Novartis revealed that its investigational heart failure medicine, LCZ696, was superior to ACE-inhibitor enalapril [current gold standard heart failure treatment] on key endpoints in the largest heart failure study ever done. In PARADIGM-HF patients with heart failure with reduced ejection fraction (HF-REF) who were given LCZ696 were more likely to be alive and less likely to have been hospitalized for sudden deterioration of their heart failure than those given ACE-inhibitor enalapril. Patients received LCZ696 or enalapril on top of current best treatment.
The LCZ696 study, involving involved more than 8,400 patients, compared the drug against enalapril, a cheap generic that is one of the most widely-prescribed treatments currently on the market.
The magnitude of benefit with LCZ696 against enalapril in HF-REF patients was highly statistically significant and clinically important. In the study, the benefit of LCZ696 was seen early, was sustained and was consistent across subgroups. LCZ696:
* reduced the risk of death from cardiovascular causes by 20% (p=0.00004)
* reduced heart failure hospitalizations by 21% (p=0.00004)
* reduced the risk of all-cause mortality by 16% (p=0.0005)
Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or heart failure hospitalization.
“By demonstrating a very significant reduction in cardiovascular deaths while improving Quality of Life, Novartis’ new heart failure medicine, LCZ696, represents one of the most important cardiology advances of the last decade,” said David Epstein, Division Head, Novartis Pharmaceuticals. “We want to thank leading cardiologists from around the world for their collaboration with us and their determination in advancing this important new life saving therapy for heart failure patients.”
Heart failure costs the world economy $108 billion each year, and hospitalizations comprise 60-70% of treatment costs.
[Wall Street Journal] Novartis expects to complete filing an application for LCZ696 with the U.S. Food and Drug Administration by the end of the year, Mr. Epstein said. The FDA has granted the drug a priority review, Mr. Epstein said, and will accept the application on a rolling submission, which allows the company to provide data as it gets it rather than wait until it has a complete package.
Roughly 26 million people in Europe and the U.S. live with chronic heart failure, according to Novartis estimates.
Deutsche Bank analysts say LCZ696 could generate up to $6 billion in peak annual sales by demonstrating the targeted 15% “mortality benefit.” Other analysts are more conservative but still see the drug generating billions of dollars in revenue.
The drug isn’t without side effects. Patients receiving LCZ696 were more likely than the enalapril group to experience hypotension, or low blood pressure, though the symptom caused very few patients to drop out of the program. Others experienced coughing, which is also a side effect of enalapril.
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