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Phathom Pharmaceuticals Inc. (PHAT) Announces FDA Acceptance for Filing of Vonoprazan NDA for the Treatment of Erosive Esophagitis

May 25, 2022 8:06 AM EDT

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today 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. In addition to experiencing troubling heartburn symptoms, patients with inadequately treated EE may progress to more severe diseases including Barrett’s esophagus, a condition in which esophageal tissue changes can progress to cancer.

“The FDA’s commencement of a substantive review of our new drug application for vonoprazan in EE is an important milestone for Phathom and the patients we seek to serve, bringing us another step closer toward the approval of a new class of treatment and the first major innovation to the U.S. GERD market in over 30 years,” said Azmi Nabulsi, M.D., Chief Operating Officer at Phathom. “With this NDA filing, we are excited about our potential to offer a treatment option to address the significant unmet needs that exist for the millions of patients suffering from painful erosions caused by all grades of EE.”

This NDA is supported by the positive data previously announced 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, following Phathom’s recent approval of vonoprazan-based therapies for treatment of H. pylori infection in adults and the FDA’s acceptance for filing of the NDA for vonoprazan for the healing and maintenance of healing of EE, the remaining $50 million is now available to be drawn down.



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