Phathom Pharma’s vonoprazan tablets gets US FDA approval for treatment of erosive esophagitis
Phathom Pharmaceuticals Inc, a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, has announced that the US FDA has approved Voquezna (vonoprazan) 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 GERD (gastroesophageal reflux disease), 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 gastrointestinal treatment landscape for patients and healthcare providers, bringing the first major innovation to the US in erosive GERD market in over 30 years,” said Terrie Curran, president and CEO of 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 US. 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.