On November 1, 2023, the U.S. Food and Drug Administration (FDA) approved Fathom Pharmaceutical’s Vonoprazan (Voquenza) for the treatment of adults with erosive esophagitis (erosive GERD), a gastroesophageal reflux disease. The drug is expected to be commercially available by December 2023.
The drug’s approval marks a significant moment for the more than 20 million patients who suffer from this disease, as it is the first major innovation in the field of erosive gastroesophageal reflux disease in the United States in the past 30 years. This drug provides fast, powerful, and powerful acid suppression. In addition to dealing with heartburn, patients with erosive gastroesophageal reflux disease who receive improper treatment can develop Barrett’s esophagus, which can lead to cancer.
The FDA has approved 10 mg and 20 mg tablets of VOQUENZ®, a potassium-competitive acid blocker, to cure all grades of erosive gastroesophageal reflux disease and reduce associated heartburn.
“This approval demonstrates Fathom’s commitment to changing the landscape of gastrointestinal care for patients and healthcare professionals and bringing the first major innovation to the U.S. erosive gastroesophageal reflux disease market in more than 30 years.” Fathom President and CEO Terry Curran said in a press release. . “Surveys show that patients and healthcare providers are largely unsatisfied with current treatments, and we hope to see first-in-class treatments that have the potential to fill significant unmet medical needs.” We are thrilled to have been approved.”
This approval is based on positive results from the Phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study of 1,024 patients with erosive gastroesophageal reflux disease in the United States and Europe. This study compared VOQUENZA and the PPI lansoprazole in terms of curing symptoms of erosive gastroesophageal reflux disease or treating associated heartburn. VOQUENZA 20 mg met the non-inferiority primary endpoint of complete healing by week 8 (P < 0.0001) in patients with all grades of erosive gastroesophageal reflux disease. The cure rate was 93%, higher than 85% with lansoprazole 30 mg.
VOQUENZA 20 mg also showed noninferiority to lansoprazole 30 mg during 24-hour heartburn-free days. For the maintenance phase of the study, VOQUENZA 10 mg was superior to lansoprazole 15 mg in consistent healing after 6 months.
Adverse events for VOQEUNZA and Lansoprazole were comparable during the healing phase and included gastritis, diarrhea, abdominal bloating, abdominal pain, and nausea. During the maintenance phase, comparable adverse events between VOQEUNZA and lansoprazole were abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“FDA approval of VOQUEZNA provides healthcare professionals with a new, first-in-class treatment option that has demonstrated rapid healing for patients with reflux esophagitis, a more difficult-to-treat form of erosive esophagitis. “We will continue to provide this to our patients,” said Dr. Colin W. Howden, Professor Emeritus of the United States. “Additionally, VOQUEZNA (vonoprazan) provides superior healing efficacy in all grades of erosive esophagitis compared to lansoprazole, a commonly prescribed PPI, and most “Provided 24-hour heartburn relief in patients”. ”
