Pharmaceutical Business review

Takeda introduces Edarbyclor drug in US

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.