Huge relief for GERD patients: Phathom Pharmaceuticals wins FDA nod for VOQUEZNA

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a pioneering biopharmaceutical company, has received U.S. Food and Drug Administration (FDA) approval for VOQUEZNA 10 mg tablets, designed to alleviate heartburn symptoms associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults. This marks VOQUEZNA’s third FDA approval, with previous endorsements for treating Erosive Esophagitis and in combination with antibiotics to eradicate Helicobacter pylori infection.

The latest FDA approval positions VOQUEZNA as the first and only treatment from a new class of acid suppression therapy accessible to a significant portion of the U.S. GERD population, estimated to affect millions. Non-Erosive GERD, the largest GERD category, involves reflux symptoms without esophageal erosions, impacting an estimated 45 million U.S. adults.

Terrie Curran, President and CEO of Phathom, expressed her enthusiasm about the approval: “Today marks a significant milestone for millions of GERD patients as we proudly announce the approval of VOQUEZNA for the treatment of Non-Erosive GERD. For decades GERD sufferers had no new class of treatment to turn to in the U.S. This approval provides patients and healthcare providers with immediate access to the first and only FDA-approved treatment of its kind, from a new class of acid suppression therapy, and the power to help provide complete 24-hour heartburn-free days and nights. We are very excited to introduce VOQUEZNA to the broader GERD community and look forward to its potential to help change the way this disease is treated.”

Colin W. Howden, M.D., Professor Emeritus at the University of Tennessee College of Medicine, underscored the importance of this development: “Millions of patients with Non-Erosive GERD continue to suffer from heartburn despite current treatment options. The pivotal study that led to this approval showed that VOQUEZNA significantly reduced heartburn episodes in patients with Non-Erosive GERD along with an established safety profile. Today’s approval of VOQUEZNA provides physicians with a novel, first-in-class treatment that can quickly and significantly reduce heartburn for many adult patients.”

The FDA’s approval is backed by results from the PHALCON-NERD-301 study, a comprehensive Phase 3 trial demonstrating VOQUEZNA’s effectiveness in significantly enhancing heartburn-free days compared to a placebo. The study involved 772 adult patients, showing that VOQUEZNA led to a 45% increase in heartburn-free days over four weeks, significantly outperforming the placebo.

VOQUEZNA’s introduction is a significant advancement in GERD treatment, reflecting Phathom Pharmaceuticals’ commitment to addressing unmet medical needs through innovative therapies. The treatment is expected to improve the quality of life for millions of individuals suffering from this chronic condition.

With VOQUEZNA now available by prescription, Phathom Pharmaceuticals continues to lead in the development of novel treatments for gastrointestinal diseases, providing substantial relief and support to the GERD community. This approval not only enhances Phathom’s portfolio but also offers a new, effective option for managing the symptoms of Non-Erosive GERD.