Takeda gains approval for Takecab in Japan; files MS drug NDA

29 December 2014

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) and partner Otsuka Pharmaceuticals (TYO: 4768) have been granted approval for their Takecab (vonoprazan fumarate; formerly code-named TAK-438) by the Japanese Ministry of Health, Labor and Welfare (MHLW) for treating acid-related diseases.

Takecab, discovered by Takeda, is a new medicine for treating acid-related diseases with a novel mechanism of action called potassium-competitive acid blockers (P-CABs) which competitively inhibits the binding of potassium ions to H+,K+-ATPase (also known as the proton pump) in the final step of gastric acid secretion in gastric parietal cells. Takecab provides a strong and sustained acid secretion inhibitory effect, the companies stated.

The approval is based on the results of multiple Phase III clinical trials for Takecab in Japan. Takeda has conducted trials for indications including gastric ulcer, duodenal ulcer, erosive esophagitis and H. pylori eradication. In these studies, Takecab demonstrated efficacy and has a favorable profile for safety and tolerability.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK