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Takeda introduces Edarbyclor drug in US

Japan's Takeda Pharmaceutical has announced that its Edarbyclor (azilsartan medoxomil and chlorthalidone) is now available by prescription in US pharmacies for the treatment of hypertension to lower blood pressure in adults.

Edarbyclor is a fixed-dose combination of two medications: azilsartan medoxomil, an angiotensin II receptor blocker (ARB), and chlorthalidone, a long-acting diuretic used in the treatment of hypertension.

In a phase 3 clinical trial, Edarbyclor (40/25 mg) was found to reduce systolic blood pressure compared to the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide at its maximum dose (40/25 mg).

In December 2011, the US Food and Drug Administration approved Edarbyclor at a recommended starting dose of 40/12.5 mg and a maximal dose of 40/25 mg.

The company said Edarbyclor may be used in patients not adequately controlled with monotherapy and as an initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals.