Takeda Announces Approval Of Takelda Combination Tablets In Japan

Takeda Pharmaceutical Company Limited announced that it has received approval for its New Drug Application (NDA) of TAKELDA Combination Tablets from the Japanese Ministry of Health, Labour and Welfare (MHLW). Takelda is a fixed dose combination (FDC) of low-dose aspirin and TAKEPRON (lansoprazole) for the treatment of peptic ulcers.

The company said that the number of patients taking low-dose aspirin for prophylaxis of cerebral infarction or myocardial infarction recurrence is rising along with the rapidly aging population in Japan. As it has been observed that the administration of low-dose aspirin may cause gastric and duodenal ulcers, prevention of onset of ulcers is critical. Domestic and international guidelines recommend combined administration with a proton pump inhibitor especially for patients with a history of gastric or duodenal ulcer.

“While TAKEPRON already has an approved indication 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. Takeda will continue to strive to provide patients and medical practitioners with highly convenient therapeutic options, while working to improve drug adherence among patients,” the company said in its press release.

TAKELDA combination tablets are indicated for the reduction of risk of thrombosis and embolism in patients with a history of gastric ulcer or duodenal ulcer. These specifically include patients who have had angina (chronic stable angina and unstable angina), myocardial infarction, and ischemic cerebrovascular disease [transient ischemic attack (TIA), cerebral infarction]. The treatment is also indicated in patients who have had coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA).

The drug is orally administered once a day in dosage of one tablet (100 mg/15 mg as aspirin/lansoprazole).