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MAA submitted for hypertension prodrug

Takeda submits European marketing authorisation application for azilsartan medoxomil, an investigational compound for essential hypertension

Takeda Global Research & Development Centre (Europe), a subsidiary of Takeda Pharmaceutical Company, has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for azilsartan medoxomil, an angiotensin II receptor blocker (ARB), for the treatment of essential hypertension. The EMA has confirmed that the submission has been validated for assessment.

The MAA submission for azilsartan medoxomil monotherapy was supported by positive results from a clinical development programme, which included nine phase III clinical trials in which approximately 7,000 subjects with essential hypertension were enrolled. Of these, 4,814 unique subjects received at least one 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.

Results from the phase III clinical trials showed azilsartan medoxomil successfully met the primary endpoints of change in 24-hour mean systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM). 

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 by Takeda builds upon its long-standing clinical experience with its previously discovered antihypertensive agent candesartan and highlights its continuend commitment to the treatment of hypertension.

In April 2010, Takeda submitted a New Drug Application (NDA) for azilsartan medoxomil to the US Food and Drug Administration (FDA). The filing is currently under regulatory review.

20th October 2010

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