FDA Accepts NDA for Investigational Hypertension Drug
The FDA has accepted the new drug application (NDA) for EZR-201, an investigational product from Ezra Innovations for the treatment of hypertension and heart failure.
The FDA has accepted the new drug application (NDA) for EZR-201, an investigational product from Ezra Innovations for the treatment of hypertension and heart failure. EZR-201 combines an angiotensin receptor blocker, valsartan, with Rubireten delivery technology.
The 505(b)(2) NDA was filed to the FDA with clinical data from 2 pharmacokintetic studies, as well as 1 clinical trial involving patients with stage 2 hypertension. There was also information on the clinical use of valsartan over the course of 20 years.
The Rubireten delivery technology is based on solubilisation and gastric retention. It allows for a more controlled drug release in the body, ensuring that chemicals reach maximum absorption.
"The FDA acceptance of our NDA for EZR-104 is an important milestone, and brings us closer to offering patients an attractive alternative treatment option for people in the U.S. with hypertension and heart failure," Joseph Fix, PhD, President and Chief Operating Officer at Ezra, said in a press release. "We continue to evaluate our strategic options for commercialization of EZR-104 in the United States, which include partnership, internal approaches, or a combination of these."
The Prescription Drug User Fee Act goal date for EZR-201 has been set for September 10, 2017. The most recent FDA acceptance indicates that the application is complete enough to receive a substantive review.