Phathom Pharmaceuticals' vonoprazan (Voquenza) sets a new standard in erosive gastroesophageal reflux disease (GERD) therapy.
The FDA granted approval to Phathom Pharmaceuticals for vonoprazan (Voquenza) tablets 10 mg and 20 mg, a potassium-competitive acid blocker for adults with all grades of erosive esophagitis. The approval marks a significant milestone in the treatment of erosive esophagitis, commonly known as erosive gastroesophageal reflux disease (GERD), bringing an innovative solution to the market for the first time in over 3 decades.
“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 said in a statement.
Erosive GERD affects approximately 20 million people in the United States, causing distressing heartburn symptoms and, if left untreated, potentially leading to severe conditions such as Barrett’s esophagus, a precursor to esophageal cancer. According to the announcement, the approval of vonoprazan offers hope to patients suffering from this debilitating condition, providing them with a much-needed solution for healing, maintenance of healing, and relief of heartburn associated with erosive GERD.
“The FDA approval of Voquenza (vonoprazan) 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,” Howden stated. “In addition, Voquenza (vonoprazan) provided superior maintenance of healing in all grades of erosive esophagitis, compared to lansoprazole, a commonly prescribed PPI [proton pump inhibitor], and provided 24-hour heartburn relief on most days in the trial.”
FDA Approved | Image Credit: chrisdorney - stock.adobe.com.jpg
The approval of vonoprazan is based on results from the phase 3 PHALCON-EE study (NCT04124926). The pivotal trial, a randomized, double-blind, multicenter study involving 1024 patients with erosive GERD in the United States and Europe, compared vonoprazan with the standard-of-care PPI, lansoprazole.
The study demonstrated that vonoprazan 20 mg met the primary end point of noninferiority, showcasing a complete healing rate of 93% compared with 85% for lansoprazole 30 mg by week 8. Particularly noteworthy was vonoprazan’s superiority in healing rates for patients with moderate to severe disease (Los Angeles grade C/D) at week 2, indicating its rapid and potent therapeutic effect.
In the maintenance phase of the trial, vonoprazan 10 mg exhibited superiority over lansoprazole 15 mg, maintaining healing at 6 months in all randomized patients. Per the study investigators, these promising results underline the efficacy and reliability of vonoprazan in providing sustained relief for patients with moderate to severe erosive GERD.
Vonoprazan exhibited comparable adverse event (AE) rates to lansoprazole in the trial. Common adverse events in the healing phase included gastritis, diarrhea, abdominal distension, abdominal pain, and nausea. During the maintenance phase, AEs like gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection were reported. However, the investigators reported these AEs were within an expected range and well tolerated by the patients.
Phathom Pharmaceuticals anticipates making vonoprazan available in the US market by December 2023. The company's achievement also comes with a financial boost, as the FDA approval entitles them to receive a $175.0 million payment under its revenue interest financing agreement.
“This approval demonstrates Phathom's commitment to changing the GI [gastrointestinal] treatment landscape for patients and health care providers, bringing the first major innovation to the US erosive GERD market in over 30 years,” said Terrie Curran, president and CEO at Phathom in the statement.
Reference
Phathom Pharmaceuticals announces FDA approval of Voquenza (vonoprazan) tablets for the treatment of erosive GERD and relief of heartburn associated with erosive GERD in adults. News release. Phantom Pharmaceuticals. November 1, 2023. Accessed November 6, 2023. https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-announces-fda-approval-voqueznar
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