Vonoprazan filed with FDA for erosive oesophagitis.- Phathom Pharma
Phathom Pharmaceuticals announced that it has submitted a new drug application (NDA) to the FDA for the use of vonoprazan as a treatment for adults for the healing of all grades of erosive oesophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn.
This NDA is based on the positive data previously announced from Phathom’s pivotal Phase III PHALCON-EE trial, a randomized, double-blind, multicenter trial that enrolled 1,024 patients with EE in the U.S. and Europe and compared vonoprazan to lansoprazole, a standard of care PPI, in the healing and maintenance of healing of EE, and heartburn symptom relief. PHALCON-EE successfully met its primary endpoints and key secondary superiority endpoints.
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