The Food and Drug Administration (FDA) has accepted for review the New Drug Application for vonoprazan as a treatment for the healing of all grades of erosive esophagitis and relief of heartburn, and maintenance of healing of all grades of erosive esophagitis and relief of heartburn.
Vonoprazan is an oral small molecule potassium-competitive acid blocker. The application is supported by data from the double-blind phase 3 PHALCON-EE trial (ClinicalTrials.gov Identifier: NCT04124926), which compared the efficacy and safety of vonoprazan to lansoprazole in 1024 patients with erosive esophagitis.
In the first phase of the trial, patients were randomly assigned to receive vonoprazan 20mg once daily or lansoprazole 30mg once daily for up to 8 weeks. Patients who achieved complete healing entered the maintenance phase, and were randomly assigned to receive vonoprazan 10mg or 20mg once daily or lansoprazole 15mg once daily for up to 24 weeks.
Results showed that vonoprazan met its primary noninferiority endpoints in both the healing and maintenance phases and demonstrated superior maintenance of healing in all patients and patients with moderate to severe disease vs lansoprazole at week 24. Noninferiority was also demonstrated when vonoprazan was compared with lansoprazole in the mean percentage of 24-hour heartburn free days over both the healing and maintenance periods.
“The FDA’s commencement of a substantive review of our New Drug Application for vonoprazan in [erosive esophagitis] is an important milestone for Phathom and the patients we seek to serve, bringing us another step closer toward the approval of a new class of treatment and the first major innovation to the US GERD market in over 30 years,” said Azmi Nabulsi, MD, Chief Operating Officer at Phathom.
A decision on the application is expected on January 11, 2023.
Vonoprazan was recently approved as part of a treatment pack for Helicobacter pylori (H. pylori) infection.
Phathom Pharmaceuticals announces FDA acceptance for filing of vonoprazan NDA for the treatment of erosive esophagitis. News release. May 25, 2022. https://www.globenewswire.com/news-release/2022/05/25/2450272/0/en/Phathom-Pharmaceuticals-Announces-FDA-Acceptance-for-Filing-of-Vonoprazan-NDA-for-the-Treatment-of-Erosive-Esophagitis.html