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Thursday, October 21, 2010

Takeda: European Marketing Authorisation Application for Azilsartan Medoxomil, an Investigational Compound for the Treatment of Essential Hypertension

October 20, 2010 – Takeda Pharmaceutical Company Limited (Takeda) announced that Takeda Global Research & Development Centre (Europe), Ltd. submitted a Marketing Authorisation Application (MAA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB), to the European Medicines Agency (EMA) for the treatment of essential hypertension. The EMA has confirmed that the submission has been validated for assessment.

Takeda Pharmaceutical
High blood pressure, or hypertension, was responsible for 7.6 million preventable deaths worldwide in 2001. Almost half (44 percent) of the adult population in Europe is affected by hypertension - much (approximately 60 percent) higher than in the United States and Canada. Discovered by Takeda, azilsartan medoxomil is a prodrug of the active moiety azilsartan, which lowers blood pressure by blocking the action of a vasopressor hormone, angiotensin II. The discovery and development of azilsartan medoxomil continues Takeda’s commitment to the treatment of hypertension, and builds upon the company’s long-standing clinical experience with its previously discovered antihypertensive agent candesartan.

The MAA submission for azilsartan medoxomil monotherapy was supported by positive results from a clinical development program which included nine phase 3 clinical trials in which approximately 7000 subjects with essential hypertension were enrolled of whom 4814 unique subjects received at least 1 dose of azilsartan medoxomil. The safety and efficacy of azilsartan medoxomil was studied for initial therapy as a once-daily oral monotherapy or for co-administration with other antihypertensive medications, including the diuretics chlorthalidone and hydrochlorothiazide, and the calcium channel blocker, amlodipine. It was also studied in comparison with olmesartan medoxomil, valsartan6 and ramipril... Takeda' Press Release -