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FDA Grants Priority Review to Heart Failure Treatment

Approval decision expected in August

The FDA has granted “priority review” status to LCZ696 (Novartis), an investigational medication for the treatment of heart failure with a reduced ejection fraction (HFrEF).

This designation accelerates the review of therapies that offer significant improvements compared with the current treatment, prevention, or diagnosis of serious conditions. For LCZ696, this status reduces the total review time from 12 to 8 months, meaning the FDA could make a decision on approval in August 2015.

The new drug application for LCZ696 was submitted under the FDA’s fast track program and was based on results from the landmark PARADIGM-HF study, which showed that LCZ696 was superior to the angiotensin-converting enzyme (ACE) inhibitor enalapril on key endpoints, including significantly reducing the risk of cardiovascular death or hospitalization for heart failure.

LCZ696, a twice-daily medication being investigated for heart failure, enhances the protective neurohormonal systems of the heart while simultaneously suppressing the harmful renin–angiotensin–aldosterone system (RAAS). Currently available drugs for the treatment of HFrEF have a high mortality rate, with up to 50% of patients dying within 5 years of a diagnosis of heart failure.

Heart failure is a significant and growing public health concern, with a high unmet need for new treatments. Every year, the disorder costs the world economy $108 billion. Hospitalizations comprise 60% to 70% of direct treatment costs.

Source: Novartis; February 13, 2015.

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