Phathom Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved both VOQUEZNA™ TRIPLE PAK™ (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA™ DUAL PAK™ (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori (H. pylori) infection in adults. VOQUEZNA treatment regimens contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years. The two New Drug Applications for these products were given priority review designation by the FDA and previously granted as qualified infectious disease products (QIDP).
“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 trial1,” said Terrie Curran, President and Chief Executive Officer at Phathom. “H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment regimens,2,3 resulting in treatment failures and complications for patients. New therapies that have the potential to address the limitations of current treatments are needed2,3 and we look forward to bringing these innovative vonoprazan-based treatment options to the millions of H. pylori sufferers in the U.S.”
Helicobacter pylori is a bacterial pathogen estimated to affect nearly 115 million people in the U.S.,4 and over the last few decades, eradication rates have dropped to below 80%.4 If left untreated, H. pylori infection can lead to serious complications, such as peptic ulcer disease and non-cardia gastric cancer.5 Acid suppressant therapy has long been established as a backbone for H. pylori treatment regimens to enhance antibiotic effectiveness.3 It was hypothesized that a more potent acid suppressant agent such as vonoprazan may help improve eradication rates of current regimens.2,3
“As a practicing physician, I am excited about the potential of two novel first-line H. pylori treatment options,” said William D. Chey, M.D., AGAF, FACG, FACP, Professor of Medicine and Chief of Gastroenterology & Hepatology at the University of Michigan. “I believe the added flexibility of having two additional effective therapies, including a dual therapy option that does not contain clarithromycin, offers the potential to improve clinical outcomes in patients with H. pylori infection.”
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