Phathom resubmits NDA for vonoprazan for erosive GERD with stability data controlling nitrosamine impurity

Phathom Pharmaceuticals, Inc.

Resubmitted vonoprazan NDA for erosive GERD to FDA after February 2023 Complete Response Letter.
Stability data from six reformulated batches show NVP levels >10-fold below 96 ng/day intake limit through 3 months.
NDA classified as Class 2 resubmission with 6-month review; 6-month stability data to be provided during review.
If approved, combined U.S. commercial launch for erosive GERD and H. pylori indications planned for Q4 2023.
Phase 3 PHALCON-EE trial enrolled 1,024 patients; compared vonoprazan to lansoprazole.

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