The U.S. Food and Drug Administration (FDA) has approved vonoprazan tablets 10 mg and 20 mg (Voquezna, Phathom Pharmaceuticals) for the cure and maintenance of healing of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), as well as relief from associated heartburn, the company announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of stomach acid than proton pump inhibitors (PPIs) and is considered a potential alternative.
Approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The multicenter, randomized, double-blind study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan to lansoprazole (Prevacid) PPI in the cure and maintenance of cure of erosive GERD and relief of associated heartburn symptoms.
As previously reported Medscape Medical Newsvonoprazan 20 mg was not inferior to lansoprazole 30 mg for complete cure at week 8 in patients with all grades of erosive GERD, with cure rates of 93% versus 85% for lansoprazole.
Additionally, vonoprazan showed higher cure rates in patients with moderate to severe disease (AL Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also not inferior to lansoprazole in terms of heartburn-free days during the recovery 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 randomized patients (79% versus 72%) and in the subgroup of patients with moderate to severe erosive lesions. GERD (75% versus 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs during the healing phase (2% with vonoprazan) were gastritis, diarrhea, abdominal distension, abdominal pain, and nausea.
The most common AEs during the maintenance phase (3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infections.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete recovery and persistent symptoms,” said Colin W. Howden, MD, professor emeritus at the University of Tennessee School of Medicine in Memphis. release.
Vonoprazan offers clinicians a new, first-in-class treatment option that has demonstrated faster recovery in the most difficult to treat GERD patients with erosive esophagitis,” added Howden.
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 filed a New Drug Application for Erosive Esophagitis and Post-Approval Supplement for the Treatment of Erosive Esophagitis. H pylori on hold until the company addresses concerns regarding the presence of nitrosamine impurities.
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