New Drug Application Approval for AZILVA® in Japan, a Treatment of Hypertension

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Press Releases

January 18, 2012

Takeda Pharmaceutical Company Limited

New Drug Application Approval for AZILVA^® in Japan, a Treatment of Hypertension

Osaka, Japan, January 18 2012 --- Takeda Pharmaceutical Company Limited (“Takeda”) announced today that its New Drug Application (NDA) for its investigational compound AZILVA (generic name: azilsartan) for the treatment of hypertension has been approved by the Ministry of Health, Labour and Welfare. Discovered by Takeda, azilsartan is an angiotensin II receptor blocker (“ARB”) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone. Azilva is a once-daily, orally administered single tablet, and the approved doses are 20 mg and 40 mg.

There were four phase 3 trials of AZILVA conducted in Japan for submission. One of the four phase 3 trials, was a multi-centre, double-blind study* with 636 patients of grade I and II hypertension to evaluate the efficacy and safety of AZILVA in comparison with Blopress^® (candesartan cilexetil), another ARB discovered and marketed by Takeda in Japan. The trial showed AZILVA was statistically superior to Blopress in lowering the change from baseline in sitting diastolic blood pressure. In addition, AZILVA was also statistically superior to Blopress in lowering the mean diastolic blood pressure and systolic blood pressure in 24 hours, daytime and night time as well as in the early morning time, measured by Ambulatory Blood Pressure Monitoring (ABPM). AZILVA was safe and well tolerated, with the safety profile comparable to Blopress.

Hypertention, or high blood-pressure, caused increased various cardiovascular risks, including stroke or heart attack and therefore it is critical to control blood pressure to reduce the risk of various cardiovascular events from happening as well as to improve patients’ post-event recovering condition. Also, as the relationship has been found between the occurrence of those cardiovascular events and blood pressure at night time and early morning time, AZILVA is thought to have ideal antihypertensive effects from the viewpoint of prevention of these cardiovascular events.

“We are delighted that AZILVA is approved in Japan,” said Nancy Joseph-Ridge, M.D., General Manager of Takeda’s Pharmaceutical Development Division. “We are confident that AZILVA, with its proven 24-hour blood-pressure control, will provide a valuable, new treatment option for hypertensive patients and the health care providers who treat them”.

*Rakugi H, Enya K, Sugiura K, et al. Comparison of the Efficacy and Safety of Azilsartan with that of Candesartan Cilexetil in Japanese Patients with Grade I-II Essential Hypertension: A Randomized, Double-blind Clinical Study. Hypertens Res (in press)

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