▎ WuXi AppTec content team editor
Today, Phathom Pharmaceuticals announced that the U.S. FDA has approved The Voquezna Triple Pak (a triple combination of vonorracin, amoxicillin, clarithromycin) and Voquezna Dual Pak (a dual combination of vonorracin, amoxicillin) for the treatment of helicobacter pylori infection in adults. The press release notes that both combinations include vonorasin, a "first-in-class" potassium-ion competitive acid blocker that is the first innovative acid-suppressing therapy approved in the United States in more than 30 years from a new drug type.
About 50% of the world's population is infected with Helicobacter pylori. Chronic inflammation provoked by Helicobacter pylori infection can lead to a range of diseases in infected people, including dyspepsia, peptic ulcer disease, stomach cancer, and mucosal-associated lymphoid tissue (MALT) lymphoma. Acid-suppressing therapy has been one of the pillars of the treatment regimen for Helicobacter pylori infection, which can enhance the effectiveness of antibiotics. Stronger acid-suppressing drugs (such as vonorasin) may increase eradication rates with current treatment regimens.
Vonorasin is a novel potassium-ion competitive acid blocker (P-CAB) that can competitively block the binding of potassium ions to hydrogen/potassium-ion ATPase, thereby rapidly inhibiting the secretion of gastric acid. Due to its long half-life and longer duration of action, Vonora is considered a potent long-acting proton pump inhibitor (PPI). The FDA has previously granted vonoprazan Triple and Dual Combination Therapy Qualified Infectious Disease Product Qualification (QIDP) and Fast Track qualification for the treatment of Helicobacter pylori infection.
▲ Vinorasson has a unique mechanism of action (Image source: Phathom Pharmaceuticals official website)
The FDA approval is based on the results of a critical Phase 3 clinical trial involving 1,046 patients. The results of the trial showed that the three-fold and dual combination therapy of vonorasan reached the main endpoint of the trial, and the eradication rate reached the non-inferiority criterion compared with the lansoprazole-based triple combination therapy. In the modified population of intent to treat (mITT), the eradication rate of the vonorasin triple combination was 84.7%, the eradication rate of the dual combination was 78.5%, and the eradication rate of the triple combination therapy of Lansoprazole was 78.8%.
▲Vonorasin combination therapy reached the main endpoint of phase 3 clinical trials (Image source: Phathom Pharmaceuticals official website)
In the entire population of patients including clarithromycin-resistant Helicobacter pylori infection, the eradication rate of the Vonorasin triple combination was 80.8% and the dual combination therapy was 77.2%, both superior to the triple combination therapy of lansoprazole (68.5%).
"The approval of the Voquezna treatment regimen gives doctors and patients two treatment options. They showed better eradication rates in the full patient population than in combination therapy based on the proton-pump inhibitor lansoprazole in key clinical trials. Ms. Terrie Curran, President and CEO of Phathom, said, "The eradication rate of Helicobacter pylori is declining due to antibiotic resistance, insufficient levels of acid suppression, and complex treatment regimens. Patients need new therapies that address the limitations of existing therapies, and we look forward to bringing Vonorasin-based treatment options to millions of people infected with Helicobacter pylori." ”
Resources:
[1] 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. Retrieved May 3, 2022, from https://www.globenewswire.com/news-release/2022/05/03/2435147/0/en/Phathom-Pharmaceuticals-Announces-FDA-Approval-of-VOQUEZNA-TRIPLE-PAK-vonoprazan-amoxicillin-clarithromycin-and-VOQUEZNA-DUAL-PAK-vonoprazan-amoxicillin-for-the-Treatment-of-H-pylo.html
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