AsianScientist (May 29, 2012) – AZILVA, a new drug from Takeda Pharmaceutical Company Limited, 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. The dosing regimen for AZILVA is a once-daily, orally administered single tablet, and the available doses are 20 mg and 40 mg.
There were four Phase III trials of AZILVA conducted in Japan for submission. One of the four Phase III trials was a multi-center, 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.
“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,” said Masato Iwasaki, Senior Vice President, Pharmaceutical Marketing Division of Takeda.
“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,” he said.
Predicted FY2012 sale of AZILVA is ¥3.5 billion and has been included in the projected consolidated results for FY2012, which was disclosed on May 11, 2012.
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