FDA approves Vonoprazan to treat erosive esophagitis

The U.S. Food and Drug Administration (FDA) approved Phathom Pharmaceuticals’ vonoprazan (Voquenza) on November 1, 2023 for the treatment of adults with erosive esophagitis (erosive GERD), a gastroesophageal reflux disease. The drug is expected to be commercially available by December 2023.

The drug’s approval marks a critical moment for more than 20 million patients suffering from this disease, as it is the first major innovation in erosive GERD in the United States in the past 30 years. The drug provides fast, powerful and strong acid suppression. In addition to heartburn, patients with erosive GERD who are not adequately treated may develop Barrett’s esophagus disease which can lead to cancer.

The FDA has approved VOQUENZ 10 mg and 20 mg tablets, a potassium-competitive acid blocker, to cure all grades of EROSIVE GERD and to relieve associated heartburn.

This approval demonstrates Phathom’s commitment to changing the gastrointestinal treatment landscape for patients and healthcare providers, bringing the first major innovation to the U.S. erosive GERD market in more than 30 years, said Terrie Curran , president and CEO of Phathom in a press release. Research has shown that patients and healthcare providers are largely dissatisfied with current treatments and we are excited by the approval of a first-in-class treatment option that has the potential to address a significant unmet medical need.

Approval was based on positive results from the Phase 3 PHALCON-EE study, a multicenter, randomized, double-blind study of 1,024 patients with erosive GERD in the United States and Europe. The study compared VOQUENZA to lansoprazole PPI in terms of curing symptoms of erosive GERD or treating associated heartburn. VOQUENZA 20 mg met the primary endpoint of non-inferiority (P < 0.0001) for complete cure at week 8 in patients with all grades of erosive GERD. The cure rate was 93%, higher than the 85% obtained with 30 mg of lansoprazole.

VOQUENZA 20 mg also showed non-inferiority to lansoprazole 30 mg during 24-hour heartburn-free days. As for the maintenance phase of the trial, VOQUENZA 10 mg was superior to lansoprazole 15 mg in terms of consistent recovery at 6 months.

Adverse events associated with VOQEUNZA and lansoprazole were comparable during the recovery phase, some of them being gastritis, diarrhea, abdominal distension, abdominal pain and nausea. For the maintenance phase, comparable adverse events between VOQEUNZA and lansoprazole were abdominal pain, dyspepsia, hypertension and urinary tract infection.

“The FDA’s approval of VOQUEZNA (vonoprazan) provides healthcare providers with a first-in-class new treatment option that has demonstrated faster recovery in more difficult-to-treat GERD patients with erosive esophagitis, said Colin W. Howden, MD, professor emeritus at the University of Tennessee College of Medicine, in the press release. Additionally, VOQUEZNA (vonoprazan) provided superior maintenance of healing in all grades of erosive esophagitis, compared to lansoprazole, a commonly prescribed PPI, and provided 24-hour heartburn relief in most cases. days. the trial.