FDA Approves VOQUEZNA for Non-Erosive GERD: Phathom Pharmaceuticals' Milestone Achievement

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a company dedicated to creating and marketing innovative treatments for gastrointestinal (GI) diseases, has announced the U.S. Food and Drug Administration (FDA) approval of VOQUEZNA® (vonoprazan) 10 mg tablets. These tablets are specifically approved for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults. Non-Erosive GERD is a prevalent condition within the U.S. GERD population, impacting millions who suffer from frequent heartburn. This marks the third FDA approval for VOQUEZNA, which is also approved for treating all severities of Erosive Esophagitis (EE), also known as Erosive GERD, and in combination with antibiotics for eradicating Helicobacter pylori (H. pylori) infection.

Terrie Curran, President and CEO of Phathom, highlighted the significance of this milestone, emphasizing that for decades, GERD patients in the U.S. had no new class of treatment available. This approval introduces the first and only FDA-approved treatment of its kind, from a new class of acid suppression therapy, offering complete 24-hour heartburn relief. Curran expressed excitement about VOQUEZNA's potential to revolutionize GERD treatment.

Non-Erosive GERD, characterized by reflux-related symptoms without esophageal mucosal erosions, is the largest category of GERD. It affects an estimated 45 million U.S. adults, with approximately 15 million treated with prescription medications annually. Despite existing treatments, many patients remain dissatisfied and continue to experience heartburn, impacting their quality of life.

Dr. Colin W. Howden, Professor Emeritus at the University of Tennessee College of Medicine, noted that many Non-Erosive GERD patients still suffer from heartburn despite current treatments. The pivotal study leading to VOQUEZNA's approval demonstrated significant reductions in heartburn episodes with a strong safety profile. This new approval provides physicians with a novel, first-in-class treatment that can significantly and quickly reduce heartburn in many adult patients.

The approval of VOQUEZNA is supported by positive results from the PHALCON-NERD-301 study (NCT05195528), a Phase 3 randomized, placebo-controlled, double-blind, multi-site U.S. trial. This study evaluated the efficacy and safety of VOQUEZNA for the daily treatment of adults with Non-Erosive GERD. It enrolled 772 adult patients who experienced heartburn for four or more days per week, with the majority having six to seven days of heartburn per week. The trial compared the effects of VOQUEZNA 10 mg to a placebo over four weeks and included a 20-week extension period where all patients received VOQUEZNA to assess long-term treatment outcomes. The results showed that VOQUEZNA significantly reduced heartburn episodes and maintained a favorable safety profile, supporting its approval for Non-Erosive GERD treatment.