April - June 2012
May 28, 2012
Takeda Pharmaceutical Company Limited
Osaka, Japan, May 28 2012 --- Takeda Pharmaceutical Company Limited (“Takeda”) announced today that AZILVA (generic name: azilsartan) is now available for the treatment of hypertension in Japan. 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 available 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® (generic name: candesartan cilexetil), another ARB discovered and marketed by Takeda in Japan. The trial showed AZILVA was superior to Blopress with statistical significance in lowering the change from baseline in sitting diastolic blood pressure. In addition, AZILVA was also superior to Blopress with statistical significance 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.
Masato Iwasaki, Senior Vice President, Pharmaceutical Marketing Division of Takeda, remarked that “Hypertension is one of the major risk factors for all cardiovascular diseases including cerebrovascular disease and myocardial infarction. According to the Japanese Society of Hypertension’s Guidelines for the Management of Hypertension (JSH 2009), there are about 40 million hypertensive patients in Japan, with about half of that number said to be not receiving satisfactory treatment. In the situation where strict management of blood pressure is required for these patients, we believe that AZILVA, having strong and persistent hypotensive effects, may offer a new therapeutic option. We will continue our earnest efforts to provide drug information for AZILVA that will be more useful for both Japanese patients and medical specialists”.
Predicted FY2012 sale of AZILVA is ¥3.5billion and has been included in the projected consolidated results for FY2012, which was disclosed on May 11, 2012.
* 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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