This site is intended for healthcare professionals
News

Vonoprazan filed with FDA for erosive oesophagitis.- Phathom Pharma

Read time: 1 mins
Published:17th Mar 2022

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.

Condition: Erosive Esophagitis
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.