FDA Approves Vonoprazan for Erosive Esophagitis

The U.S. Food and Drug Administration (FDA) on November 1 approved vonoprazan (Voquenza) tablets 10 mg and 20 mg, a novel potassium-competitive acid blocker (PCAB), as a new treatment for adults for the healing of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), maintenance of healing of all grades of erosive GERD, and relief of heartburn associated with erosive GERD.

Erosive GERD affects approximately 20 million people in the U.S. It causes heartburn symptoms and without adequate treatment can lead to more severe diseases, including Barrett’s esophagus and eventually to esophageal cancer.

This approval is based on positive results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that enrolled 1,024 patients with erosive GERD in the U.S. and Europe. This study compared vonoprazan to the proton pump inhibitor lansoprazole in the healing of erosive GERD, maintenance of healing, and associated heartburn symptom relief. 

Vonoprazan 20 mg met the primary endpoint of noninferiority to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD (93% vonoprazan to 85% lansoprazole.

Adverse event rates for vonoprazan were comparable to lansoprazole throughout the trial. The most common adverse events reported among patients who received vonoprazan during the healing phase of the study include gastritis, diarrhea, abdominal distension, abdominal pain, and nausea; during the maintenance phase patients reported gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.

Vonoprazan is manufactured by Phathom Pharmaceuticals.