Phathom Pharmaceuticals has obtained the Food and Drug Administration’s clearance for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a novel potassium-competitive acid blocker, as a new treatment for adults for the healing of all grades of erosive esophagitis, maintenance of healing of all grades of erosive GERD and relief of heartburn associated with erosive GERD.
“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 CEO 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.”
Erosive GERD, also referred to as erosive esophagitis or erosive acid reflux, is a major type of GERD that affects approximately 20 million people in the United States. In addition to experiencing troubling heartburn symptoms, patients with inadequately treated erosive GERD may develop more severe diseases including Barrett’s esophagus, a condition in which esophageal tissue changes can progress to cancer, the company said.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” said Colin Howden, professor emeritus at the University of Tennessee College of Medicine. “The FDA approval of Voquezna (vonoprazan) 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, 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 on most days in the trial.”
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Voquezna is expected to be available in December 2023 and will be marketed exclusively by Phathom Pharmaceuticals.