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Tuesday, September 26, 2023

Phathom: Vonoprazan NDA Submission for Non-Erosive GERD

 

  • Submission based on positive results from Phase 3 PHALCON-NERD-301 in which vonoprazan 10 mg and 20 mg controlled heartburn symptoms through the entire 6 months of the study with a safety profile consistent with prior vonoprazan studies

  • New drug application (NDA) seeks U.S. Food and Drug Administration (FDA) approval for vonoprazan as a daily treatment for Non-Erosive GERD, the largest subcategory of GERD with an estimated U.S. adult population of 38 million

  • FDA action date for Non-Erosive GERD NDA expected in the third quarter of 2024

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