Takeda gets US regulatory backing for Edarbyclor

21 December 2011

The US Food and Drug Administration yesterday approved Edarbyclor (azilsartan medoxomil and chlorthalidone) a combination therapy from Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) for the treatment of hypertension to lower blood pressure in adults.

Takeda says Edarbyclor is the only fixed-dose therapy in the USA to combine an angiotensin II receptor blocker (ARB) with the diuretic chlorthalidone in a once-daily, single tablet. The recommended starting dose of Edarbyclor is 40/12.5mg and the maximum dose is 40/25mg.

The two medications in Edarbyclor work to help lower blood pressure in patients with hypertension. Azilsartan medoxomil, marketed as Edarbi I in the USA and recently approved in Europe (The Pharma Letter December 12), reduces blood pressure by blocking the action of angiotensin II, a vasopressor hormone that naturally exists within the body. Chlorthalidone reduces the amount of water in the body by increasing the flow of urine, which helps to lower blood pressure, the company explained.

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