Voquezna back on track with FDA approval for erosive esophagitis, heartburn relief
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The FDA has approved Phathom Pharmaceuticals’ Voquezna tablets 10 mg and 20 mg to treat erosive esophagitis, or erosive gastroesophageal reflux disease, and alleviate heartburn associated with the disease, noted a company release.
This decision comes after the agency had rejected Phathom’s new drug application for Voquezna (vonoprazan) in February, citing the presence of nitrosamine impurities. The FDA had requested that the company provide “additional stability data to demonstrate that levels” of the impurity would remain at or below the daily acceptable intake throughout the shelf life of the product.
“This approval demonstrates Phathom’s commitment to changing the GI treatment landscape for patients and health care providers, bringing the first major innovation to the U.S. erosive GERD market in over 30 years,” Terrie Curran, president and CEO of Phathom, said in a press release. “Erosive GERD can be extremely painful and often has a significant impact on patients. Research has shown patients and health care 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.”
The FDA based its decision on positive results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study among patients with erosive GERD (n=1,024) who received either Voquezna or the proton pump inhibitor lansoprazole to evaluate healing and maintenance of healing for erosive GERD and associated heartburn relief.
According to study results, Voquezna 20 mg achieved its primary endpoint of noninferiority (P <.0001) for complete healing at week 8 in patients with all grades of erosive GERD, with a healing rate of 93% vs. 85% for lansoprazole 30 mg. Voquezna demonstrated superior healing rates among patients with moderate-to-severe disease at week 2 compared to lansoprazole (70% vs. 53%; P =.0008). Voquezna also showed noninferiority to lansoprazole in the mean percentage of 24-hour heartburn free days during the healing period.
During the study’s maintenance phase, Voquezna 10 mg demonstrated superiority to lansoprazole 15 mg in maintaining healing at six months in all randomized patients (79% vs. 72%), especially in a subset of patients with moderate-to-severe erosive GERD (75% vs. 61%) (P=.0490). Voquezna 10 mg was also evaluated for heartburn relief in patients with erosive GERD and demonstrated noninferiority to lansoprazole 15 mg at 6 months.
“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 at the University of Tennessee College of Medicine, said in the release. “The FDA approval of Voquezna provides health care providers with a new first-in-class therapeutic option that demonstrated faster healing in the more difficult to treat GERD patients with erosive esophagitis. In addition, Voquezna provided superior maintenance of healing in all grades of erosive esophagitis, compared to lansoprazole, a commonly prescribed PPI, and provided 24-hour heartburn relief on most days in the trial.”
The adverse event rates for Voquezna were found to be comparable to lansoprazole throughout the trial, the company noted. The most common adverse events reported in patients who received Voquezna during the healing phase of the study include gastritis, diarrhea, abdominal distension, abdominal pain and nausea; during the while patients in the maintenance phase of the study reported gastritis, abdominal pain, dyspepsia, hypertension and urinary tract infection.
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