FDA approves Voquezna to relieve erosive esophagitis, heartburn, back on track

The FDA has approved Phathom Pharmaceuticals’ Voquezna tablets 10 mg and 20 mg to treat erosive esophagitis, or erosive gastroesophageal reflux disease, and to relieve heartburn associated with the disease.

The decision comes after the FDA rejected Phathom’s new drug application for Voquezna (vonoprazan) in February, citing the presence of nitrosamine impurities. The FDA asked the company to provide “additional stability data to demonstrate that the level of the impurity” remains at or below the acceptable daily intake throughout the product’s shelf life.

“This approval demonstrates Phathom’s commitment to changing the gastrointestinal treatment landscape for patients and healthcare providers, bringing the first major innovation to the U.S. erosive gastroesophageal reflux disease market in more than 30 years,” Terry CurranPhathom President and CEO said in a press release. “Erosive gastroesophageal reflux disease can be extremely painful and often has significant consequences for patients. Research shows that patients and healthcare providers are largely dissatisfied with current treatments, and we are pleased with the approval of a first-in-class treatment option We are excited about the potential of this solution to address a large unmet medical need.”

The FDA’s decision is based on positive results from the Phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study of patients with erosive GERD (n= 1,024) to assess healing and efficacy in maintaining healing of erosive gastroesophageal reflux disease and relieving associated heartburn.

According to the study results, Voquezna 20 mg met the primary endpoint of non-inferiority (ask <.0001) For patients with all grades of erosive GERD who were completely healed at week 8, the healing rate was 93% vs. 85% for lansoprazole 30 mg. Compared with lansoprazole, Voquezna demonstrated higher cure rates at week 2 in patients with moderate to severe disease (70% vs. 53%; ask =.0008). Voquezna also showed noninferiority to lansoprazole in the average percentage of 24-hour heartburn-free days during the healing period.

In the maintenance phase of the study, Voquezna 10 mg showed superiority to lansoprazole 15 mg in maintaining healing after six months in all randomized patients (79% vs. 72%), particularly in moderate to severe erosions subset of patients with chronic GERD (75% vs. 61%) (ask=.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, response to current treatments is suboptimal, resulting in incomplete healing and persistent symptoms,” Colin W. Howerton, MDProfessor Emeritus at the University of Tennessee College of Medicine said in a news release. “FDA approval of Voquezna provides healthcare providers with a new first-in-class treatment option that has shown faster healing effects for the most difficult-to-treat GERD patients with erosive esophagitis. Additionally, in combination with lansoprazole (a commonly used proton pump inhibitor), Voquezna provided better maintenance of healing in all grades of erosive esophagitis and provided 24-hour heartburn relief for most of the trial.”

The company noted that Voquezna’s adverse event rate was comparable to that of lansoprazole throughout the trial. The most common adverse events reported by patients treated with Voquezna during the healing phase of the study included gastritis, diarrhea, bloating, abdominal pain, and nausea; during this period, patients in the maintenance phase of the study reported gastritis, abdominal pain, dyspepsia, hypertension, and urinary Road infection.