Phathom Pharmaceuticals, which focuses on developing and commercializing treatments for gastrointestinal diseases, announced it has submitted to the FDA six-month stability data from its long-term and accelerated stability program for its reformulated vonoprazan tablets. The additional stability was required for the FDA to complete its NDA review for vonoprazan, a novel potassium-competitive acid blocker (PCAB), for the treatment of Erosive GERD (gastroesophageal reflux disease), also referred to as erosive esophagitis.
The NDA seeks regulatory approval for vonoprazan as a treatment for the healing and maintenance of healing of Erosive GERD, and relief of associated heartburn symptoms, and was previously classified as a Class 2 resubmission with a six-month review period. If approved, a combined U.S. commercial launch for Erosive GERD and H. pylori is planned for the fourth quarter of 2023.