FDA Approves Voquezna (vonoprazan) for the Treatment of Erosive GERD and Relief of Heartburn Associated with Erosive GERD in Adults

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November 1, 2023 - Phathom Pharmaceuticals, Inc. a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced that the U.S. Food and Drug Administration (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.

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 U.S. 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.

Voquenza could cause serious side effects, including kidney issues, diarrhea from intestinal infection, bone fractures, and severe skin reactions.

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