Feb 6 2012
Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., announced EDARBYCLOR (azilsartan medoxomil and chlorthalidone) is now available by prescription in U.S. pharmacies for the treatment of hypertension to lower blood pressure in adults. It is the only fixed-dose therapy in the U.S. to combine an angiotensin II receptor blocker (ARB) with chlorthalidone in a once-daily, single tablet. In a phase 3 clinical trial, the systolic blood pressure reductions of the maximum dose of EDARBYCLOR (40/25 mg), by both clinic and trough 24-hour ambulatory blood pressure monitoring, were shown to be statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide at its maximum dose (40/25 mg). Additionally, similar blood pressure lowering effects of EDARBYCLOR were observed in a sub-group analysis of black patients.
EDARBYCLOR is a fixed-dose combination of two medications: azilsartan medoxomil, an ARB, and chlorthalidone, a long-acting diuretic used in the treatment of hypertension. Azilsartan medoxomil is approved under the trade name EDARBI in the U.S., Europe and Mexico. The two medications work to help lower blood pressure levels in patients with hypertension. EDARBYCLOR was approved by the U.S. Food and Drug Administration on December 20, 2011, at a recommended starting dose of 40/12.5 mg and a maximal dose of 40/25 mg.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks. There are no controlled trials of EDARBYCLOR demonstrating reductions in cardiovascular risk in patients with hypertension; however, trials with chlorthalidone and at least one drug similar to azilsartan medoxomil have demonstrated such benefits.
"February is American Heart Month and it's important to recognize that nearly 40 percent of hypertension patients are not at their blood pressure targets, putting them at increased cardiovascular risk," said Douglas Cole, president, Takeda Pharmaceuticals U.S.A., Inc. "We're pleased to bring EDARBYCLOR to market and expand the EDARBI family of products to help appropriate patients with hypertension work towards reaching their blood pressure goals."