Takeda's Vonoprazan Fumarate Tablets Receive New Indication Approval in China for Helicobacter pylori Eradication

By | Pharma Insights

On October 13, a public notice from China's National Medical Products Administration (NMPA) disclosed that Takeda's application for a new indication for vonoprazan fumarate tablets has been approved in China. Publicly available information indicates that vonoprazan is a novel potassium-competitive acid blocker (P-CAB) that was previously approved in China for the treatment of reflux esophagitis. Based on clinical trial information for vonoprazan in China, it is speculated that the newly approved indication for this drug is likely for the treatment of *Helicobacter pylori* infection in combination with other antibiotics.

Screenshot source: NMPA official website

Vonoprazan is a novel acid-suppressing drug developed by Takeda. By blocking the K+ channel of H+/K+-ATPase, it competitively inhibits the binding of K+ to the enzyme and remains in gastric parietal cells for an extended period, thereby rapidly suppressing gastric acid secretion. Due to its long half-life and prolonged duration of action, vonoprazan is considered an effective long-acting proton pump inhibitor (PPI).

In February 2015, vonoprazan was launched in Japan. Currently, the drug has been approved in Japan for multiple indications, including reflux esophagitis, gastric ulcer, duodenal ulcer, prevention of recurrence of gastric or duodenal ulcers, and eradication of Helicobacter pylori.

In China, vonoprazan was first approved in December 2019 for the treatment of reflux esophagitis, becoming the first potassium-competitive acid blocker (P-CAB) to enter the Chinese market and providing a novel acid-suppressive therapy for adult patients with reflux esophagitis. In April 2020, Takeda submitted marketing authorization applications in China for two new indications of vonoprazan tablets, which were accepted. The approval of these new indications means that vonoprazan tablets will benefit a broader population of patients in China.

According to publicly available information on ClinicalTrials.gov, Takeda is currently conducting multiple clinical trials in patients in China. Among these, the trial furthest along in progress is a randomized, double-blind Phase 3 clinical study designed to evaluate the efficacy and safety of vonoprazan quadruple therapy (in combination with amoxicillin, clarithromycin, and bismuth) versus esomeprazole quadruple therapy for the treatment of *Helicobacter pylori* infection. Based on this, it can be inferred that the newly approved indication for vonoprazan is highly likely to be "treatment of *Helicobacter pylori* infection in combination with other antibacterial drugs."

References:

[1] Release of Information on Drug Approval Documents Pending Collection on October 13, 2021. Retrieved Oct 13, 2021, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20211013145120134.html

[2] Takeda's Novel-Mechanism Acid-Suppressive Drug Vonoprazan Launches, Ushering in a New Era of Acid-Suppression Therapy. Retrieved May 11, 2020, from https://www.prnasia.com/story/279654-1.shtml

[3]Clinicaltrials.gov. Retrieved Oct 11, 2021, from https://clinicaltrials.gov/ct2/show/NCT04198363?term=vonoprazan&spons=Takeda&cntry=CN&draw=2&rank=3

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