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FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
Date:12/20/2011

DEERFIELD, Ill. and OSAKA, Japan, Dec. 20, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced today that the U.S. Food and Drug Administration (FDA) approved EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults. EDARBYCLOR is the only fixed-dose therapy in the U.S. 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 40/12.5 mg and the maximum dose is 40/25 mg.

The two medications in EDARBYCLOR work to help lower blood pressure in patients with hypertension. Azilsartan medoxomil, marketed as EDARBI in the U.S., reduces blood pressure by blocking the action of angiotensin II, a vasopressor hormone that naturally exists within the body. When EDARBI blocks the angiotensin II receptor, blood vessels can stay relaxed and open, and blood pressure can be reduced. Chlorthalidone reduces the amount of water in the body by increasing the flow of urine, which helps to lower blood pressure. Prior landmark clinical outcomes trials have demonstrated that chlorthalidone is effective in reducing blood pressure in patients with hypertension and that long-term use is associated with reductions in serious hypertension-related complications.

"Hypertension is a complex disease that affects one in three Americans. It is critical to control hypertension because lowering blood pressure has been shown to reduce the risk of serious health consequences, including stroke and heart attack," said Domenic Sica, M.D., professor of internal medicine and nephrology at Virginia Commonwealth University Medical Center. "The approval of EDARBYCLOR provides an effective treatment option to lower blood pressure for appropriate patients with hypertension who may require a combination of drugs to help achieve b
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SOURCE Takeda Pharmaceuticals North America, Inc.
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