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Phathom Pharmaceuticals Resubmits Erosive GERD New Drug Application to FDA
Anticipated FDA action date in Q4 2023; if approved, combined launch for Erosive GERD and H. pylori indications planned before year endIf approved, vonoprazan
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"Anticipated FDA action date in Q4 2023; if approved, combined launch for Erosive GERD and H. pylori indications planned before year endIf approved, vonoprazan would be the first innovative acid suppressant from a new drug class approved for the treatment of Erosive GERD in the U.S. in over 30 years FLORHAM PARK, N.J., May 23, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), 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). This resubmission responds to the Complete Response Letter (CRL) issued by the FDA in February 2023 relating to specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan (NVP). As previously communicated, Phathom implemented mitigation measures, including a minor drug product tablet reformulation, to inhibit the growth of NVP, and has been conducting a stability program to demonstrate these measures are effective and support the commercial shelf life. “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 dat...