Voquezna FDA Approval History
Last updated by Judith Stewart, BPharm on July 21, 2024.
FDA Approved: Yes (First approved November 1, 2023)
Brand name: Voquezna
Generic name: vonoprazan
Dosage form: Tablets
Company: Phathom Pharmaceuticals, Inc.
Treatment for: Erosive Esophagitis, GERD, Helicobacter Pylori Infection
Voquezna (vonoprazan) is a potassium-competitive acid blocker (P-CAB) for use in the treatment of erosive and non-erosive gastroesophageal reflux disease (GERD) and the combination treatment of Helicobacter pylori infection.
- Voquezna is indicated:
- for healing of all grades of erosive esophagitis (also known as erosive gastroesophageal reflux disease) and relief of heartburn associated with erosive esophagitis in adults.
- to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.
- for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults.
- in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection in adults.
- in combination with amoxicillin for the treatment of H. pylori infection in adults. - Erosive esophagitis is a condition characterized by the presence of erosions in the esophageal tissue caused by constant irritation of the mucosal surface and subsequent loss of defense mechanisms against acid and digestive enzymes. Non-Erosive GERD is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions.
- Voquezna is a potassium-competitive acid blocker that works to help heal esophagitis and to relieve heartburn by suppressing basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H+, K+-ATPase enzyme system in a potassium-competitive manner.
- Voquezna tablets are taken once daily, with or without food.
- Warnings and precautions associated with Vonoprazan include an increased risk of clostridioides difficile-associated diarrhea (CDAD), risk of bone fracture, severe cutaneous adverse reactions, vitamin B12 deficiency, hypomagnesemia, interference with diagnostic investigations for neuroendocrine tumors, and increased risk of fundic gland polyps.
- Common adverse reactions:
- in patients receiving treatment for healing of erosive esophagitis include gastritis, diarrhea, abdominal distension, abdominal pain, and nausea.
- in patients receiving maintenance treatment for healed erosive esophagitis include gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
- in patients receiving treatment for the relief of heartburn associated with non-erosive gastroesophageal reflux disease include abdominal pain, constipation, diarrhea, nausea, and urinary tract infection.
- in patients receiving treatment for H. pylori infection include diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, and nasopharyngitis. - In 2022, the FDA approved two combination products containing vonoprazan: Voquezna Triple Pak (vonoprazan, amoxicillin, and clarithromycin) and Voquezna Dual Pak (vonoprazan and amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection in adults.
Development timeline for Voquezna
Further information
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