The US Food and Drug Administration (FDA) has approved vonoprazan 10 mg and 20 mg tablets (Voquezna, Phathom Pharmaceuticals) for the healing and maintenance of healing of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
As previously reported by Medscape Medical News, vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate-to-severe disease (LA Grade C/D) at week 2 (70% vs 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs 72%) and in the subset of patients with moderate-to-severe erosive GERD (75% vs 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
"For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms," Colin W. Howden, MD, professor emeritus, University of Tennessee College of Medicine, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis," Howden added.
Vonoprazan is expected to be available in the United States next month.
Earlier this week, the FDA approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the post-approval supplement for H pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
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Lead image: Phathom Pharmaceuticals
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Cite this: FDA OKs New Treatment for Erosive Esophagitis - Medscape - Nov 02, 2023.
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