FDA Approves 2 Vonoprazan Therapies for H pylori

The U.S. Food and Drug Administration (FDA) granted approval for 2 new treatments for Helicobacter pylori (H pylori) in adults on May 3.

Voquenza Triple Pak combines vonoprazan tablets — a novel potassium-competitive acid blocker—with 2 antibiotics, amoxicillin capsules and clarithromycin tablets. Voquenza Dual Pak includes vonoprazan tablets and amoxicillin capsules.

These treatments were approved under priority review and qualify as infectious disease products, according to the drugs’ manufacturer, Phathom Pharmaceuticals. The phase 3 PHALCON-HP clinical trial of Voquenza showed superiority over the current regimen of proton pump inhibitor lansoprazole triple therapy in eradicating H pylori.

Rates of H pylori eradication have been decreasing in the US due in part to the development of antibiotic resistance.

Voquenza Triple and Dual Paks are expected to be available in the U.S. in the third quarter of 2022, according to Phathom.

—Rebecca Mashaw

Reference:
Phathom Pharmaceuticals announces FDA approval of Voquenza Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquenza Dual Pak (vonoprazan, amoxicillin) for the treatment of H. pylori infection in adults. [Press release.] May 3, 2022. Accessed May 5, 2022. https://www.globenewswire.com/news-release/2022/05/03/2435147/0/en/Phathom-Pharmaceuticals-Announces-FDA-Approval-of-VOQUEZNA-TRIPLE-PAK-vonoprazan-amoxicillin-clarithromycin-and-VOQUEZNA-DUAL-PAK-vonoprazan-amoxicillin-for-the-Treatment-of-H-pylo.html