Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Takeda Pharmaceutical has filed a new drug application (NDA) with the Ministry of Health, Labour and Welfare (MHLW) for its experimental treatment for hypertension, TAK-536 (generic name: azilsartan).
Subscribe to our email newsletter
Takeda has submitted the NDA for the compound on the basis of the results from four Phase 3 clinical trials conducted in Japan.
In those trials, Takeda has evaluated the safety and efficacy of TAK-536 in comparison with Blopress (candesartan cilexetil); another angiotensin II receptor blocker (ARB) discovered and marketed by Takeda in Japan.
The trial involved slightly more than 1,000 patients, out of all four trials; one trial evaluated around 636 patients in Japan.
The trial which involved 636 patients demonstrated that TAK-536 was statistically superior to Blopress in lowering the change from baseline in sitting diastolic blood pressure, which is the primary endpoint.
TAK-536 was found to be safe and well tolerated, with the safety profile comparable to Blopress.
Takeda Pharmaceutical Development Division general manager Nancy Joseph-Ridge said if approved, they expect that TAK-536 will provide a valuable, new treatment option for hypertensive patients and the health care providers who treat them, and at the same time, enhance their presence in hypertension drug market in Japan.