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news.Swiss drug-maker Novartis has secured priority review designation from the US Food and Drug Administration (FDA) for its investigational medicine LCZ696, to treat heart failure with reduced ejection fraction (HFrEF).
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The company has submitted a new drug application (NDA) under the FDA’s fast track program and is based on results from the PARADIGM-HF trial, which is claimed to be the largest ever conducted in heart failure.
The trial showed that LCZ696 was superior to ACE-inhibitor enalapril on key endpoints as well as significantly reduced the risk of CV death or heart failure hospitalization.
For LCZ696, the designation reduces the total review time from 12 to 8 months, meaning the FDA could make a decision on approval in August 2015.
Novartis Pharmaceuticals division head David Epstein said: "LCZ696 is a demonstration of our commitment to developing innovative medicines that improve important heart failure related outcomes such as cardiovascular mortality, hospitalization and quality of life.
"The FDA’s decision reflects the significant need to extend and improve life for HFrEF patients and Novartis is working to ensure LCZ696 can become available in the US as soon as possible."
In the European Union (EU), the European Medicines Agency’s (EMA’s) the Committee for Medicinal Products for Human Use (CHMP) has also granted accelerated assessment to LCZ696.
LCZ696, which is being investigated for heart failure, has a new mode of action which is expected to reduce the strain on the failing heart.
The twice a day medicine will help in improving the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).