• 19 Jul 2024
• Admin
• News Article

Phathom Scores Non-Erosive GERD Approval for Heartburn Drug

Overview

Already approved for erosive gastroesophageal reflux disease, Phathom’s Voquenza is now authorized to treat patients with non-erosive GERD.

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 & GERD

• 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. 

Statement from an Expert

“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.

About Voquezna

• 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.

Non-erosive GERD & Voquezna

• 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 Approvals

• 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.

Phathom Launch

• 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.