Ezra Innovations NDA for Hypertension Drug

FDA has accepted for review an Ezra Innovations NDA for investigational drug product EZR-104 for treating hypertension and heart failure. The agency has set a user fee review target date of 9/10. EZR-104 combines angiotensin receptor blocker valsartan with its Rubireten delivery technology. “This novel formulation is designed to control the release of the active drug throughout the 24-hour dosing period and overcome diminished blood concentrations of the drug when administered with a meal, an effect commonly associated with previously approved forms of valsartan,” the company says. “The 505(b)(2) NDA filed in support of this drug contains clinical data developed by Ezra, including two pharmacokinetic studies and one clinical trial in patients with Stage 2 hypertension, and references data from extensive clinical use of valsartan over the past 20 years.”