Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Erosive GERD
Phathom Pharmaceuticals, Inc. recently announced the US FDA has acknowledged that its New Drug Application (NDA) resubmission for vonoprazan, a novel first-in-class potassium-competitive acid blocker (PCAB), for the treatment of Erosive GERD (gastroesophageal reflux disease) constitutes a complete response to the February 2023 complete response letter (CRL). The FDA has classified this as a Class 2 resubmission and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023.
“We are thrilled to announce the FDA has set a PDUFA goal date of November 17, 2023, for our Erosive GERD NDA and has acknowledged that our resubmission responds to the nitrosamine related issues cited in the complete response letter we received earlier this year and allows the Agency to continue its review of our NDA,” said Terrie Curran, President and Chief Executive Officer of Phathom. “This significant milestone brings us one step closer to the approval of a new class of treatment for Erosive GERD representing the first major innovation to the U.S. GERD market in over 30 years. We eagerly await the potential approval of vonoprazan and the combined launch of both Erosive GERD and H. pylori indications in the fourth quarter.”
The NDA resubmission, which was submitted in response to the CRL issued by the FDA in February 2023, contained three months of stability data of reformulated vonoprazan tablets to support the commercial shelf life of vonoprazan. Phathom will continue to provide additional stability data during the regulatory review as previously agreed with FDA as part of this resubmission.
Erosive GERD (gastroesophageal reflux disease), also known as Erosive Esophagitis, is a major type of GERD characterized by erosions in the gastric mucosa caused by acidic reflux of stomach contents into the esophagus. There are estimated to be over 65 million individuals with GERD in the US, of which approximately 30% have Erosive GERD. In addition to experiencing troubling heartburn symptoms, patients with inadequately treated Erosive GERD may progress to more severe diseases including Barrett’s esophagus and esophageal cancer.
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights in the US, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). For more information, visit www.phathompharma.com.
Total Page Views: 1065
