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FDA grants priority review for investigational HF treatment
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Novartis announced that the FDA has granted a priority review designation to its investigational LCZ696 for the treatment of patients with HF and reduced ejection fraction, according to a press release.
LCZ696 consists of the angiotensin receptor blocker valsartan bonded to the neprilysin inhibitor sacubitril.
The priority review designation will shorten the FDA review time for the drug from 12 months to 8 months, according to the release.
The new drug application for LCZ696, submitted under the FDA Fast Track program, follows results from the PARADIGM-HF trial, which demonstrated that LCZ696 significantly reduced risk for HF-related hospitalization and CV mortality compared with the ACE inhibitor enalapril. Patients assigned LCZ696 also reported better quality of life, and the drug was associated with an acceptable safety profile, according to the release.
“The FDA’s decision reflects the significant need to extend and improve life for [HF with reduced ejection fraction] patients, and Novartis is working to ensure LCZ696 can become available in the US as soon as possible,” David Epstein, division head, Novartis Pharmaceuticals, said in the release.
Disclosure: Epstein is an employee of Novartis Pharmaceuticals.