Based on the terms of Phathom’s revenue interest financing agreement, the FDA approval of Voquenza for Erosive GERD also entitles the company to receive a $175 million payment. This non-dilutive capital will help fund the commercial launch. “This approval demonstrates Phathom's commitment to changing the GI treatment landscape for patients and healthcare providers, bringing the first major innovation to the U.S. Erosive GERD market in over 30 years,” said Terrie Curran, president, and chief executive officer at Phathom. “Erosive GERD can be extremely painful and often has a significant impact on patients. Research has shown patients and healthcare providers are largely unsatisfied with current treatments and we are excited about the approval of a first-in-class treatment option that has the potential to meet a large unmet medical need.” googletag.cmd.push(function () {
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This approval is based on positive results from the Phase 3 PHALCON-EE study. The pivotal trial was a randomized, double-blind, multicenter study that enrolled 1,024 patients with erosive GERD in the US and Europe and compared Voquenza to the PPI lansoprazole in the healing and maintenance of healing of Erosive GERD and associated heartburn symptom relief. Results showed that Voquenza 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, with superior rates of healing demonstrated in a secondary endpoint in patients with the moderate-to-severe disease (LA Grade C/D) at week 2 compared to lansoprazole (70% for Voquenza 20 mg and 53% for lansoprazole 30 mg). Voquenza 20 mg also demonstrated non-inferiority to lansoprazole 30 mg in the mean percentage of 24-hour heartburn-free days over the healing period. In the maintenance phase of the trial, Voquenza 10mg was superior to lansoprazole 15 mg in maintaining healing at six months in all randomized patients (79% for Voquenza 10 mg, compared to 72% for lansoprazole 15mg) as well as in the subset of patients with moderate-to-severe erosive GERD (75% for Voquenza 10mg, compared to 61% for lansoprazole 15mg). In addition, Voquenza 10mg was evaluated as a secondary endpoint for relief of heartburn in erosive GERD patients and demonstrated non-inferiority to lansoprazole 15mg over six months. “The FDA approval of Voquenza provides healthcare providers with a new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with Erosive Esophagitis. In addition, Voquenza provided superior maintenance of healing in all grades of Erosive Esophagitis, compared to lansoprazole, a commonly prescribed PPI, and provided 24-hour heartburn relief on most days in the trial.”