Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA® (vonoprazan) Tablets for the Relief of Heartburn Associated with Non-Erosive GERD in Adults

Core Insights - VOQUEZNA has received FDA approval for the treatment of Non-Erosive Gastroesophageal Reflux Disease (GERD), marking a significant advancement in GERD treatment in over 30 years [1][4][12] - The approval is based on the successful results of the Phase 3 pivotal trial, which demonstrated a significant reduction in heartburn episodes among patients [6][7] - VOQUEZNA is the first and only FDA-approved treatment of its kind available in the U.S., providing a new class of acid suppression therapy for patients [2][4] Company Overview - Phathom Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases [14] - The company has in-licensed the U.S. rights to vonoprazan, the active ingredient in VOQUEZNA, from Takeda, which markets the product in Japan and other regions [13][14] - Phathom is committed to providing savings programs for eligible patients facing coverage or affordability issues [9] Industry Context - Non-Erosive GERD is the largest category of GERD, affecting an estimated 45 million U.S. adults, with around 15 million treated with prescription medications annually [5][12] - Despite existing treatment options, many patients remain dissatisfied and continue to experience heartburn, impacting their quality of life [5][6] - The introduction of VOQUEZNA is expected to change the treatment landscape for GERD, offering patients a new option for relief [2][6]