The US Food and Drug Administration (FDA) has approved two vonoprazan-based treatments for Helicobacter pylori infection: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.
Vonoprazan is an oral potassium-competitive acid blocker and "the first innovative acid suppressant from a new drug class approved in the US in over 30 years," the company said in a news release announcing the approval.
"The approval of Voquezna treatment regimens offers physicians and patients two therapeutic options that showed superior eradication rates compared to proton pump inhibitor-based (PPI) lansoprazole triple therapy in the overall patient population in a pivotal trial," Terrie Curran, president and CEO of Phathom Pharmaceuticals, said in the release.
"H pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment regimens, resulting in treatment failures and complications for patients," Curran noted.
"New therapies that have the potential to address the limitations of current treatments are needed and we look forward to bringing these innovative vonoprazan-based treatment options to the millions of H pylori sufferers in the US," Curran said.
FDA approval of vonoprazan triple and dual therapy was based on safety and efficacy data from the phase 3 PHALCON-HP trial involving 1046 patients.
