Phathom submits NDA to FDA for vonoprazan as daily Non-Erosive GERD treatment

Phathom Pharmaceuticals, Inc.

NDA for vonoprazan as daily treatment for Non-Erosive GERD in adults submitted to FDA, supported by Phase 3 PHALCON-NERD-301 study.
Primary endpoint met: 45% (10 mg) and 44% (20 mg) heartburn-free days vs 28% placebo (p<0.0001).
20-week extension study showed 61-63% heartburn-free days for vonoprazan doses.
FDA review expected 10 months; potential Q3 2024 U.S. launch if approved.
Vonoprazan under review for Erosive GERD with PDUFA date Nov 17, 2023; Q4 2023 launch planned if approved.

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