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Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis
FLORHAM PARK, N.J., March 14, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"FLORHAM PARK, N.J., March 14, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of 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. Erosive esophagitis, a major type of gastroesophageal reflux disease (GERD), 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 submission of this NDA is another exciting step towards bringing the first major innovation to the U.S. GERD market in over 30 years,” said Azmi Nabulsi, M.D., Chief Operating Officer at Phathom. “Proton pump inhibitors (PPIs) are currently the standard of care for EE yet approximately half of all U.S. patients progress their lines of therapy annually. We believe there is great interest among patients and healthcare providers for new treatment options to address the shortcomings of current treatment. If approved, vonoprazan has the potential to satisfy the large unmet needs of millions of patients and set a new treatment paradigm in EE.” This NDA is based on the positive data previously announced from Phathom’s pivotal Phase 3 PHALCON-EE trial, a randomized, double-blind, multicenter trial that enrolled 1,024 patients with EE in the U.S. and Europe and compared vonoprazan to lansoprazole, a standard of care 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. About Erosive EsophagitisErosive esophagitis is a condition characterized by the presence of breaks, or erosions, in the esophageal tissue caused by constant irritation of the mucosal surface and subsequent loss of defense mechanisms against acid and digestive enzymes. Chronic erosive esophagitis can lead to complications including peptic stri...