Phathom Pharmaceuticals' Nda Resubmission for Erosive Gerd Accepted by Fda
Tuesday, June 13, 2023
Phathom Pharmaceuticals, Inc. has made an announcement regarding the progress of its New Drug Application (NDA) for vonoprazan, a novel treatment for Erosive GERD (gastroesophageal reflux disease). The company received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in February 2023, outlining certain issues related to nitrosamine. However, Phathom has now resubmitted the NDA, which the FDA has classified as a Class 2 resubmission.
The FDA has acknowledged that the resubmission adequately addresses the concerns raised in the CRL, and as a result, the agency has assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023, for the completion of the review process. Phathom is pleased with this development, as it brings the company closer to potentially gaining approval for vonoprazan, a new class of treatment for Erosive GERD.
Phathom Pharmaceuticals aims to introduce both the Erosive GERD and H. pylori indications in the fourth quarter, should the FDA approve vonoprazan. The company plans to provide additional stability data for the reformulated vonoprazan tablets during the regulatory review, as agreed with the FDA.
Erosive GERD, also known as Erosive Esophagitis, is a significant form of GERD characterized by erosions in the gastric mucosa caused by the reflux of acidic stomach contents into the esophagus. It is estimated that over 65 million individuals in the U.S. have GERD, and approximately 30% of them suffer from Erosive GERD. Inadequately treated Erosive GERD can lead to more severe conditions like Barrett's esophagus and esophageal cancer.
