FDA Approves Two Products for H pylori Infection

The FDA approved vonoprazan, amoxicillin, and clarithromycin (Voquezna Triple Pack) and vonoprazan, amoxicillin (Voquezna Dual Pak) for the treatment of Helicobacter pylori (H pylori) infection in adults. Vonoprazan, a novel, first-in-class potassium-competitive acid blocker, demonstrated superior eradication rates versus proton pump inhibitor–based lansoprazole-based triple therapy in the overall patient population of the pivotal phase 3 trial.

The approvals were based on safety and efficacy data from the phase 3 PHALCON-HP trial, which randomized 1,046 patients. In the modified intent-to-treat population, both vonoprazan treatment regimens demonstrated noninferiority to lansoprazole triple therapy in patients without a clarithromycin- or amoxicillin-resistant strain of H pylori at baseline. The H pylori eradication rate was 84.7% with the triple-therapy vonoprazan product and 78.5% with the dual-therapy vonoprazan product compared with 78.8% with lansoprazole triple therapy.

In the overall study population, eradication rates of H pylori for the vonoprazan double- and triple-therapy products were 77.2% and 80.8%, respectively, versus 68.5% with lansoprazole triple therapy; eradication rates in patients who had a clarithromycin-resistant strain of H pylori were 69.6% and 65.8% versus 31.9%, respectively.

The new treatments are products of Phathom Pharmaceuticals. For full prescribing information consult product labeling.

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