Phathom announces FDA acceptance of NDA resubmission for vonoprazan

Phathom Pharmaceuticals announced that the U.S. Food and Drug Administration has acknowledged that its New Drug Application resubmission for vonoprazan, a novel potassium-competitive acid blocker, for the treatment of Erosive GERD constitutes a complete response to the February 2023 complete response letter. The FDA has classified this as a Class 2 resubmission and assigned a Prescription Drug User Fee Act goal date of November 17, 2023. 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.