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

• FDA approval marks the first major innovation to the U.S. Erosive GERD market in over 30 years
• VOQUEZNA® met the primary endpoints and key secondary superiority endpoints in the pivotal Phase 3 PHALCON-EE trial evaluating VOQUEZNA in comparison to a standard-of-care proton pump inhibitor (PPI)1
• Commercial availability of VOQUEZNA expected December 2023
• Erosive GERD approval provides Phathom $175 million under its revenue interest financing agreement
• Conference call and webcast scheduled for November 2, 2023, at 11:00 a.m. ET

FLORHAM PARK, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today the U.S. Food and Drug Administration (FDA) has approved VOQUEZNA® (vonoprazan) tablets 10 mg and 20 mg, a novel potassium-competitive acid blocker (PCAB), as a new treatment for adults for the healing of all grades of Erosive Esophagitis, also known as Erosive GERD (gastroesophageal reflux disease), maintenance of healing of all grades of Erosive GERD, and relief of heartburn associated with Erosive GERD.2

“This approval demonstrates Phathom's commitment to changing the GI treatment landscape for patients and healthcare providers, bringing the first major innovation to the U.S. Erosive GERD market in over 30 years,” said Terrie Curran, President and Chief Executive Officer at Phathom. “Erosive GERD can be extremely painful and often has a significant impact on patients. Research has shown patients and healthcare providers are largely unsatisfied with current treatments and we are excited about the approval of a first-in-class treatment option that has the potential to meet a large unmet medical need.”

Erosive GERD, also referred to as Erosive Esophagitis or Erosive Acid Reflux, is a major type of GERD that affects approximately 20 million people in the U.S.3,4 In addition to experiencing troubling heartburn symptoms, patients with inadequately treated Erosive GERD may develop more severe diseases including Barrett’s esophagus, a condition in which esophageal tissue changes can progress to cancer.3

This approval is based on positive results from the Phase 3 PHALCON-EE study (NCT04124926). The pivotal trial was a randomized, double-blind, multicenter study that enrolled 1,024 patients with Erosive GERD in the U.S. and Europe and compared VOQUEZNA to the PPI lansoprazole in the healing and maintenance of healing of Erosive GERD and associated heartburn symptom relief.1   

Results showed that VOQUEZNA 20 mg met the primary endpoint of non-inferiority (p