Phathom Gets Approval for GERD Drug

FDA has approved a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a potassium-competitive acid blocker for treating adults with all grades of erosive esophagitis (also known as erosive gastroesophageal reflux disease (GERD)) and relief of heartburn associated with erosive GERD.

Approval is based on data from the Phase 3 PHALCON-EE study (NCT04124926) that showed Voquezna 20 mg met the primary endpoint of non-inferiority for complete healing by Week 8 in patients with all grades of erosive GERD with a healing rate of 93% compared to 85% for lansoprazole 30 mg, the company reports. “Voquezna 20 mg also demonstrated non-inferiority to lansoprazole 30 mg in the mean percentage of 24-hour heartburn-free days over the healing period,” it says, adding that adverse event rates for the drug were comparable to lansoprazole in the trial.