January - March 2009
January 21, 2009
Takeda Pharmaceutical Company Limited
-Fixed dose combination tablet of Blopress® and diuretic for treatment of hypertension-
Osaka, Japan, January 21, 2009 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that a New Drug Application for ECARD, a fixed dose combination tablet of Blopress (generic name: candesartan cilexetil) and a low-dose diuretic (generic name: hydrochlorothiazide) for treatment of hypertension, was approved on January 21 by the Japanese Ministry of Health, Labour and Welfare.
ECARD is a tablet taken orally once daily and the two approved formulations are “ECARD LD” and “ECARD HD”; 4mg candesartan cilexetil / 6.25mg hydrochlorothiazide and 8mg candesartan cilexetil / 6.25mg hydrochlorothiazide, respectively.
Discovered by Takeda, Blopress is an angiotensin II* receptor blocker (“ARB”), which was launched in 1999 and became the first ARB in Japan in 2005 with an indication of chronic heart failure. Hydrochlorothiazide is classified as a thiazide diuretic and lowers blood pressure by increasing the flow of urine, which results in lowered extracellular fluid volume.
*Angiotensin II is well known as a potent vasopressor hormone.
ECARD is a fixed dose combination tablet of an ARB and a diuretic, a low-dose concomitant therapy which is recommended by the Guidelines for the Management of Hypertension in Japan. By reducing the hydrochlorothiazide dose to 6.25mg, which is a quarter of the ordinary clinical dosage, it is believed that commonly-experienced adverse events of thiazide diuretics can be lessened. An enhancement in anti hypertensive effect was also demonstrated in the phase III clinical trial.
“We believe that the fixed dose combination tablet of Blopress with a diuretic will be able to offer better control of blood pressure to patients with hypertension,” said Masaomi Miyamoto, Ph.D., General Manager of Pharmaceutical Development Division of Takeda. “We also expect that this product approval will further maximize the value of Blopress and enhance our hypertension franchise in Japanese market.”
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