Phathom scores non-erosive GERD approval for heartburn drug
Phathom Pharmaceuticals has secured another indication for its acid suppression drug. The FDA expanded Voquezna’s label Thursday to include heartburn relief associated with non-erosive gastroesophageal reflux disease.
Voquezna (vonoprazan) was already approved for erosive gastroesophageal reflux disease (GERD), but non-erosive GERD is the largest category of the disease, according to the company. GERD is one of the most prevalent conditions worldwide. An estimated 15 million people in the U.S. are treated with prescription drugs for the non-erosive disease type each year, compared to approximately 7 million with erosive GERD.
“Millions of patients with non-erosive GERD continue to suffer from heartburn despite current treatment options. 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,” Colin Howden, a professor at the University of Tennessee College of Medicine, said in a statement.
Voquezna is a potassium-competitive acid blocker (P-CAB) that travels to the proton pump to prevent it from working to produce acid. Proton pump inhibitors (PPIs) like esomeprazole have long been the mainstay treatment for various types of reflux. Research suggests Voquezna carries advantages of higher efficacy, more rapid onset, longer durability and superior safety over the traditional PPIs.
In the pivotal trial for non-erosive GERD patients, Voquezna quickly and significantly reduced heartburn with daily treatment compared to placebo over four weeks, with the median percentage of heartburn-free days being 48% vs. 17%. Long-term treatment was also evaluated in a 20-week extension.
Voquezna is also approved in combination with antibiotics to treat patients with H. pylori infection. Phathom’s first full quarter launch of the drug—its first and currently only approved product—brought in $1.9 million in sales, according to its earnings report released in May. Earlier this year, a Needham analyst predicted $55.6 million in total sales in 2024, above the $46 million consensus estimate.
Takeda and Frazier Healthcare Partners launched Phathom in 2019 to develop and commercialize vonoprazan in the U.S., Europe and Canada. Takeda retained rights with Otsuka to co-market the drug in Japan and several other Asian markets.
Source: BioSpace
