Novartis announced today that the US Food and Drug Administration (FDA) has granted priority review for LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF). The designation is intended to accelerate the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. For LCZ696, this reduces the total review time from 12 to 8 months, meaning the target FDA action date is in August 2015.
"The FDA's decision to grant priority review brings us one step closer to making this promising treatment available to the millions of Americans who are struggling with this debilitating condition," said Christi Shaw, US Country Head, President of Novartis Corporation and President of Novartis Pharmaceuticals Corporation. "LCZ696 has the potential to change the way that many heart failure patients are treated in this country, giving them and their loved ones greater hope for their future."
The New Drug Application (NDA) is based on results from the landmark PARADIGM-HF study, the largest ever conducted in heart failure. The study showed LCZ696 was superior to the accepted guideline therapy ACE-inhibitor enalapril on key endpoints, including the primary endpoint, which showed reduction of the risk of either cardiovascular death or heart failure hospitalization by 20%.
In the European Union, the Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ696.
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