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Phathom Pharmaceuticals Announces Regulatory Update and Plans for 2023 Erosive Esophagitis and H. pylori Commercial Launch
Favorable feedback following meeting with the U.S. Food and Drug Administration (FDA) allows for planned resubmission of erosive esophagitis new drug
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"Favorable feedback following meeting with the U.S. Food and Drug Administration (FDA) allows for planned resubmission of erosive esophagitis new drug application (NDA) this quarterCombined commercial launch of vonoprazan for erosive esophagitis and H. pylori indications expected Q4 2023, if approved FLORHAM PARK, N.J., April 04, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today provided a regulatory update following its recent meeting with the FDA regarding the complete response letters (CRLs) for Phathom’s erosive esophagitis NDA and H. pylori post approval supplement (PAS) to VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® NDAs. Both CRLs were solely related to specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan (NVP). Since first detecting trace levels of NVP, Phathom conducted extensive root cause investigations and implemented mitigation measures, including a minor tablet reformulation, to inhibit the growth of NVP. Phathom has shared available stability data with the FDA on this reformulation and received feedback on the resubmission requirements, including the expected stability data requirements. Based on this input, Phathom anticipates resubmitting the NDA for erosive esophagitis in the second quarter of 2023 which, if approved, could lead to a combined commercial launch of the erosive esophagitis and H. pylori indications in the fourth quarter of 2023. Phathom also anticipates submitting a PAS for VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® with FDA action expected in the fourth quarter of 2023. “We are very pleased with the outcome of our FDA meeting and the clear feedback we received from the Agency regarding requirements to obtain potential regulatory approvals for both erosive esophagitis and H. pylori before year end,” said Terrie Curran, President and Chief Executive Officer of Phathom. “We believe the data package, including stability data that we have shared with the Agency, and which we continue to generate, demonstrate that the mitigation measures we have implemented are successfully achieving their intended effects of limiting and controlling NVP, the sole deficiency noted in the prior CRLs. We appreciate the regulator...