FDA Approves Voquezna for GERD Treatment

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Phathom Pharmaceuticals announced that FDA has approved non-erosive GERD treatment Voquezna. Non-erosive GERD, or gastroesophageal reflux disease can cause heartburn, which Voquezna has been approved to treat. This is the third FDA approval for the medication, which is also approved to treat all severities of erosive esophagitis and for the eradication of H. pylori infection (when used in combination with antibiotics).

In a press release, Phathom CEO and president Terrie Curran said, “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.”

In the same press release, Colin W. Howden, MD, professor emeritus at the University of Tennessee’s College of Medicine, said, “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.”

Prior to this approval, Phathom had presented the results of a Phase III study investigating the use of Voquezna as a treatment for NERD, non-erosive reflux disease. The data was presented at the Digestive Disease Week conference in Washington D.C.

In a press release issued at the time, Phathom’s chief medical officer Eckhard Liefke, MD, said, “This year’s abstracts showcase the breadth of the data we will be presenting at DDW, reaffirming Phathom’s continued commitment to helping improve the lives of people affected by acid-related gastrointestinal disorders. Notably, we are excited to unveil novel findings highlighted in three posters and an oral presentation during the conference, including the first-time data from our Phase 3 study of the investigational use of Voquezna in Non-Erosive GERD will be presented during a medical congress. Our team eagerly anticipates meaningful interactions with physicians that treat the conditions we are working to transform.”

Earlier this year, in March, Phathom launched an direct-to-consumer advertising campaign for Voquezna that featured on various platforms, such as Facebook, Instagram, and waiting rooms in doctors’ offices. The campaign features the tagline “Voquezna can kick some acid.”

At the time of the campaign’s launch, the company’s chief commercial officer Martin Gilligan said, “Phathom is excited to launch our first campaign directly to, and for, the people whose lives we strive to improve every day. Although Erosive GERD is a highly symptomatic condition that can have a detrimental impact on millions of patients, there has been little medical innovation in this category in decades, until now. We believe our new DTC campaign is accessible, memorable, and informative. Our goal is to connect with people unsatisfied with their current treatment options and empower them to explore the power of Voquezna with their healthcare provider.”

Sources

1. Phathom Pharmaceuticals Announces FDA Approval of Voquezna (vonoprazan) Tablets for the Relief of Heartburn Associated with Non-Erosive GERD in Adults. Phathom Pharmaceuticals. July 18, 2024. https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-announces-fda-approval-voqueznar-0
2. Phathom Pharmaceuticals to Present Voquezna (vonoprazan) Data at DDW 2024 Annual Meeting. Phathom Pharmaceuticals. May 15, 2024. Accessed July 18, 2024. https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-present-voqueznar-vonoprazan-data-ddw
3. Phathom Pharmaceuticals Launches Direct-to-Consumer Campaign, “Voquezna Can Kick Some Acid.” Phathom Pharmaceuticals. March 26, 2024. Accessed July 18, 2024. https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-launches-direct-consumer-campaign