Takeda Receives NDA Approval For Gastric Ulcer And Hypertension Drugs

Takeda’s two new fixed dose combination drugs, TAKELDA® and Zacras®, receive approval from the Japanese Ministry of Health, Labor and Welfare.

AsianScientist (Mar. 27, 2014) – Takeda Pharmaceutical Company Limited have received approval for two new drug applications (NDA) from the Japanese Ministry of Health, Labor and Welfare (MHLW). Both are fixed dose combination (FDC) drugs, one for gastric ulcers and the other for high blood pressure.

The first drug, TAKELDA®, combines 100 mg aspirin with 15 mg lansoprazole (TAKEPRON) and is the first FDC drug in Japan to combine low-dose aspirin with a proton pump inhibitor.

The number of patients taking low-dose aspirin for prevention of the recurrence of cerebral infarction or myocardial infarction is increasing along with the rapidly aging population in Japan. However, low-dose aspirin may cause the gastric and duodenal ulcers, therefore, domestic and international guidelines recommend combined administration with a proton pump inhibitor, especially for patients with a history of gastric or duodenal ulcer.

TAKEPRON was already approved for prevention of the recurrence of ulcers in patients who require administration of low-dose aspirin for a longer period while preventing the onset of ulcers. However, making it a FDC drug has made it more convenient and helps prevent patients from missing a dose, which will enable patients to take low-dose aspirin over the long term while controlling the occurrence of ulcers.

The second drug, Zacras®, is a combination of the blood pressure lowering azilsartan and the calcium channel blocker amlodipine. It is used for treating hypertension.

The application approval was based on results of Phase III clinical trials conducted in Japan. The multi-center, randomized, double-blind controlled trial with 603 patients concluded that the combination was superior to drugs in isolation.

Given the demand for appropriate blood pressure control that fits the clinical conditions of individual patients, the FDC of azilsartan and amlodipine is a new beneficial hypertension treatment option that is expected to further help control blood pressure for patients.

——

Source: Takeda.

Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

Asian Scientist Magazine is an award-winning science and technology magazine that highlights R&D news stories from Asia to a global audience. The magazine is published by Singapore-headquartered Wildtype Media Group.

Related Stories from Asian Scientist