Biopharmaceutical company Phathom Pharmaceuticals, Inc. (PHAT) announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn.
The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023.
Vonoprazan is a novel, orally administered investigational potassium-competitive acid blocker (PCAB) from a new class of acid suppressant agents and under development for the treatment of erosive esophagitis and non-erosive gastroesophageal reflux disease (NERD).
Erosive esophagitis is a major type of gastroesophageal reflux disease (GERD) and affects approximately 20 million people in the U.S.
This NDA is based on the positive data from Phathom’s pivotal Phase 3 PHALCON-EE trial, a randomized, double-blind, multicenter trial that enrolled 1,027 patients with EE in the U.S. and Europe and compared vonoprazan to lansoprazole, a proton pump inhibitor (PPI), in the healing and maintenance of healing of EE, and heartburn symptom relief. PHALCON-EE successfully met its primary endpoints and key secondary superiority endpoints.
Under the terms of Phathom’s loan agreement with Hercules Capital, the remaining $50 million is now available to be drawn down.
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