Perspective from Adrienna Jirik, MD
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Press Release

May 04, 2022
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FDA approves two vonoprazan treatment regimens for H. pylori infection

Perspective from Adrienna Jirik, MD
Source:

Press Release

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Phathom Pharmaceuticals Inc. has announced FDA approval for its Voquezna Triple and Dual Paks for the treatment of Helicobacter pylori infection in adults.

According to a press release, the new drug applications for Voquenza Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets; Phathom Pharmaceuticals) and Voquenza Dual Pak (vonoprazan tablets, amoxicillin capsules; Phathom Pharmaceuticals) were given priority review designation by the FDA after previous classification as qualified infectious disease products. Both regimens contain vonoprazan, an innovative potassium-competitive acid blocker, and are supplied in blister packs to promote compliance.

Sign outside FDA HQ in Washington, DC.
The FDA approved Phathom Pharmaceuticals Inc.'s Voquenza Triple and Dual Paks for the treatment of H. pylori infection. Source: Adobe Stock

“These new regimens usher in the next generation of H. pylori treatment,” William D. Chey, MD, AGAF, FACG, FACP, professor of medicine and chief of gastroenterology and hepatology at the University of Michigan, told Healio. “Vonoprazan provides more profound and durable gastric acid suppression than traditional [proton pump inhibitors (PPIs)] that, when used empirically, translate into higher eradication rates than PPI-based triple therapy.”

In the pivotal phase 3 PHALCON-HP trial, which randomized 1,046 patients with H. pylori to one of the vonoprazan treatment regimens or lansoprazole triple therapy, the two regimens demonstrated noninferiority compared with lansoprazole triple therapy in patients without a clarithromycin or amoxicillin resistant H. pylori strain. Vonoprazan also showed superior eradication rates vs. PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) in all patients, including those with clarithromycin-resistant strains of H. pylori.

In the overall study population, the H. pylori eradication rate was 80.8% with the Voquenza Triple Pak vs. 68.5% with lansoprazole triple therapy; similarly, the eradication rate was 77.2% with the Voquenza Dual Pak vs. 68.5% with lansoprazole triple therapy.

Phathom Pharmaceuticals expects to launch the vonoprazan treatment regimens in the United States in the third quarter of 2022.