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The FDA approved two vonoprazan-based regimens, one with amoxicillin and clarithromycin (Voquezna Triple Pak), and one with amoxicillin (Voquezna Dual Pak), to treat Helicobacter pylori (H. pylori) infection in adults, drugmaker .

Both regimens contain antibiotics co-packaged with vonoprazan, a potassium-competitive acid blocker (PCAB), the first acid suppressant from a new drug class approved in the U.S. in over 30 years. PCABs work by inhibiting acid secretion in the stomach, which allows vonoprazan to achieve pH levels that result in improved antibiotic effectiveness.

"As a practicing physician, I am excited about the potential of two novel first-line H. pylori treatment options," said William D. Chey, MD, of the University of Michigan in Ann Arbor, 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."

Approval was based on data from the pivotal phase III randomized , in which both the combination and triplet showed noninferiority to the proton pump inhibitor (PPI)-based lansoprazole triple therapy (with amoxicillin and clarithromycin) among 1,046 patients, making it the largest H. pylori trial in the U.S., according to Phathom.

In the modified intent-to-treat population, the H. pylori eradication rate was 84.7% with the vonoprazan-based triplet and 78.5% with the doublet compared with 78.8% with lansoprazole triple therapy.

For the overall study population, the H. pylori eradication rate was 80.8% with the vonoprazan-based triplet and 77.2% with the doublet versus 68.5% with lansoprazole triple therapy, while those with a clarithromycin-resistant strain had slightly lower rates (65.8%, 69.6%, and 31.9%, respectively).

H. pylori is estimated to affect about 115 million people in the U.S., and H. pylori infection can lead to serious complications -- peptic ulcers, dyspepsia, mucosa-associated lymphoid tissue lymphoma, and non-cardia gastric cancer -- if left untreated. Prior studies have shown that one out of four patients fail first-line therapy with PPI-based clarithromycin triple therapy.

Adverse events with the vonoprazan-based treatments were similar to those with lansoprazole triple therapy. The most common (≥2%) adverse events included dysgeusia, diarrhea, abdominal pain, headache, nasopharyngitis, hypertension, and vulvovaginal candidiasis.

The dual and triple regimens are contraindicated for those with hypersensitivities to vonoprazan, amoxicillin, or any of its formulation components. Other warnings include the risk of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and Clostridioides difficile-associated diarrhea. The triplet also includes a warning on QT prolongation due to the clarithromycin component.

Both the doublet and triplet come in blister packs to support treatment compliance and are expected to be available in the U.S. by the third quarter of 2022.

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