FDA Approves Pair of Vonoprazan Treatments for Helicobacter Pylori Infection

The Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) were previously granted priority review designation by the FDA for H. pylori infection.

The (FDA) has approved 2 vonoprazan-based medications for the treatment of Helicobacter pylori (H. pylori) infection.

Phathom Pharmaceuticals announced the approvals of both the Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) based on positive safety and efficacy data from the phase 3 PHALCON-HP trial.

The treatment regimen includes antibiotics packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) that is the first acid suppressant from a new drug class approved in the United States in more than 30 years, according to Phathom Pharmaceuticals.

Both New Drug Applications for Voquezna were granted priority review designation by the FDA and previously granted as qualified infectious disease products.

“The approval of Voquezna treatment regimens offers physicians and patients 2 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 CEO of Phathom, in a press 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. 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.”

The current standard care for H. pylori treatment is an acid suppressant, which highlights the need for vonoprazan, according to Phathom Pharmaceuticals. PCABs block acid secretion in the stomach and vonoprazan has shown an ability to achieve pH levels that increase the efficacy of antibiotics.

The phase 3 PHALCON-HP trial included 1046 patients, which Phathom said is the largest H pylori trial ever conducted in the United States. Both the vonoprazan dual and triple therapy regimens were found non-inferior to lansoprazole triple therapy in patients without an H. pylori strain resistant to clarithromycin or amoxicillin.

The H. pylori eradication rate was 84.7% for vonoprazan triple therapy and 78.5% for the dual therapy, versus a 78.8% eradication rate with lansoprazole. The 2 treatments were found superior to PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) in all patients, including those with clarithromycin resistant strains of H. pylori.

Adverse events (AEs) with the vonoprazan-based treatments were similar to those of lansoprazole triple therapy. The most common AEs affecting more than 2% of patients in the trial were diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, and nasopharyngitis.

H. pylori is a bacterial pathogen that affects an estimated 115 million people in the United States, according to Phathom Pharmaceuticals. If left untreated, the infection can lead to serious complications, including peptic ulcer disease and non-cardia gastric cancer.

“As a practicing physician, I am excited about the potential of 2 novel first-line H. pylori treatment options,” William D. Chey, MD, AGAF, FACG, FACP, professor of Medicine and chief of Gastroenterology & Hepatology at the University of Michigan, said in a press release. “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.”

Reference

Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults. Phathom Pharmaceuticals. News release. May 4, 2022.