regulatory
confidence high
sentiment positive
materiality 0.75
FDA approves reformulated vonoprazan for H. pylori; launch expected Dec 2023
Phathom Pharmaceuticals, Inc.
- FDA approved prior approval supplements for reformulated vonoprazan tablets in VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for H. pylori infection in adults.
- Product expected to be available in the U.S. in December 2023 and marketed exclusively by Phathom.
- H. pylori infects an estimated 115 million individuals in the U.S.; 36% of the U.S. population estimated to be infected.
- Phathom planning combined U.S. commercial launch of H. pylori regimens and Erosive GERD vonoprazan, if approved.