Posted by Michael Wonder on 14 Mar 2022
Phathom Pharmaceuticals submits vonoprazan NDA to FDA for the treatment of erosive oesophagitis
14 March 2022 - Phathom Pharmaceuticals announced today that it has submitted a new drug application to the U.S. FDA for the use of vonoprazan as a treatment for adults for the healing of all grades of erosive eosophagitis and relief of heartburn, and maintenance of healing of all grades of erosive oesophagitis and relief of heartburn.
This new drug application is based on the positive data previously announced from Phathom’s pivotal Phase 3 PHALCON-EE trial, a randomised, double-blind, multi-centre 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 erosive oesophagitis, and heartburn symptom relief.
