FDA approves Voquezna Triple Pack andVoquezna Dual Pack to treat Helicobacter pylori infection.

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 trial,” 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, resulting in treatment failures and complications for patients. 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 U.S".

The US approvals were based on safety and efficacy data from the Phase III PHALCON-HP trial, the largest U.S. registrational trial ever conducted in H. pylori, randomizing 1,046 patients. In the modified intent-to-treat population, both Voquezna treatment regimens demonstrated non-inferiority 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 Voquezna Triple Pak compared to 78.8% with lansoprazole triple therapy [95% CI: -0.8, 12.6] and 78.5% for Voquezna Dual Pak compared to 78.8% with lansoprazole triple therapy [95% CI: -7.4, 6.8]. Voquezna Triple Pak and Voquezna Dual Pak demonstrated superior eradication rates compared to PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) among all patients, including in patients with clarithromycin resistant strains of H. pylori. The H. pylori eradication rate with Voquezna Triple Pak was 80.8% versus 68.5% with lansoprazole triple therapy in the overall study population [95% CI: 5.7, 18.8] and in patients who had a clarithromycin-resistant strain of H. pylori, 65.8% vs. 31.9%, respectively [95% CI: 17.7, 48.1].1H. pylori eradication rates for Voquezna Dual Pak were 77.2% versus 68.5% with lansoprazole triple therapy in the overall study population [95% CI: 1.9, 15.4] and in patients who had a clarithromycin-resistant strain of H. pylori, 69.6% vs. 31.9%, respectively [95% CI: 20.5, 52.6].

Adverse event (AE) rates for the vonoprazan-based regimens were comparable to lansoprazole triple therapy in the trial. The most common AEs (>2.0%) reported in the Voquezna Triple Pak, Voquezna Dual Pak, and lansoprazole triple therapy arms, respectively, were diarrhea (4.0%, 5.2%, 9.6%), dysgeusia (4.6%, 0.6%, 6.1%), vulvovaginal candidiasis (3.2%, 2.0%, 1.4%), abdominal pain (2.3%, 2.6%, 2.9%), headache (2.6%, 1.4%, 1.4%), hypertension (2.0%, 1.1%, 0.9%) and nasopharyngitis (0.3%, 2.0%, 0.9%).

Helicobacter pylori is a bacterial pathogen estimated to affect nearly 115 million people in the U.S., and over the last few decades, eradication rates have dropped to below 80%. If left untreated, H. pylori infection can lead to serious complications, such as peptic ulcer disease and non-cardia gastric cancer. Acid suppressant therapy has long been established as a backbone for H. pylori treatment regimens to enhance antibiotic effectiveness. It was hypothesized that a more potent acid suppressant agent such as vonoprazan may help improve eradication rates of current regimens.