Phathom Pharmaceuticals Resubmits New Drug Application for Erosive GERD to FDA

Company seeks FDA approval for innovative treatment targeting Erosive GERD

Phathom Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it has resubmitted its New Drug Application (NDA) for vonoprazan, a novel first-in-class potassium-competitive acid blocker (PCAB), for the treatment of Erosive GERD (gastroesophageal reflux disease), also referred to as erosive esophagitis, to the U.S. Food and Drug Administration (FDA).

“We are very pleased to announce the resubmission of our NDA seeking approval for vonoprazan as the first innovative acid suppressant for the treatment of Erosive GERD in the U.S. in over 30 years,” said Terrie Curran, President and Chief Executive Officer of Phathom. “Our resubmission includes three-months of stability data required by the FDA to reinitiate their review and demonstrates the reformulation is proving effective in limiting the presence of NVP and controlling its growth well below the FDA’s acceptable daily intake limit. As agreed with the Agency, we plan to provide the final six-month stability data during their review as it becomes available. The data we have collected so far, and our statistical modeling, reinforce our confidence that the reformulated vonoprazan tablets comfortably support the 24-month shelf life we originally requested. We are excited with the progress we have made and look forward to the potential approval of our NDA later this year.”

The NDA resubmission contains three months of stability data for six batches of the reformulated vonoprazan tablets. The three-month data demonstrate that Phathom’s mitigation measures are controlling NVP growth through three months and keeping levels well below the acceptable daily intake limit of 96 ng/day or 2.4 ppm (parts per million) based on the maximum approved daily dose of 40 mg/day. All of the manufactured reformulated batches have demonstrated control of NVP through three months of long-term stability conditions that are more than tenfold below the acceptable intake limit and which Phathom believes support the requested shelf life of 24 months based on its statistical modeling. In addition, the NDA is supported by extensive clinical data including efficacy and safety data from Phathom’s pivotal Phase 3 PHALCON-EE trial, a randomized, double-blind, multicenter trial that enrolled 1,024 patients with Erosive GERD in the U.S. and Europe and compared vonoprazan to lansoprazole, a proton pump inhibitor (PPI), in the healing and maintenance of healing of Erosive GERD, and relief of associated heartburn symptoms.

Phathom expects the NDA to be classified as a Class 2 resubmission with a six-month review period and plans to provide the FDA with six-month stability data from its ongoing stability program during the regulatory review process. If the NDA is approved, a combined U.S. commercial launch for the Erosive GERD and H. pylori indications is planned for the fourth quarter of 2023.  

Published on : 24th May, 2023