FDA clears Takeda Edarbyclor fixed-dose combination regimen

21st December 2011 (Last Updated December 21st, 2011 18:30)

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceutical's Edarbyclor as a treatment for hypertension in adults.

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceutical's Edarbyclor as a treatment for hypertension in adults.

Edarbyclor, a once-daily single tablet regimen, is a fixed-dose combination therapy of azilsartan medoxomil and diuretic chlorthalidone, with a recommended starting dose of 40/12.5mg and the maximum dose is 40/25mg.

Azilsartan medoxomil, marketed as Edarbi in the US, reduces blood pressure by blocking the action of angiotensin II, while chlorthalidone acts by reducing the amount of water in the body and increasing the flow of urine.

Virginia Commonwealth University Medical Center Internal medicine and Nephrology professor Domenic Sica said the approval of Edarbyclor offers an effective treatment option to lower blood pressure for appropriate patients with hypertension who may require a combination of drugs to help attain blood pressure goals.

"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," Sica added.

Takeda Pharmaceutical Medical & Scientific affairs executive medical director Paulos Berhanu said in clinical trials, Edarbyclor reported significant blood pressure reductions and was found to be superior to the fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide at maximum respective doses.

The safety and efficacy of Edarbyclor, ranging from eight weeks to 52 weeks in duration, with doses of azilsartan medoxomil/chlorthalidone ranging from 20/12.5 to 80/25mg once daily was evaluated in the five Phase III clinical studies.

The studies showed that Edarbyclor lowered mean trough systolic blood pressure, reduced blood pressure in black and non-black patients at similar levels, as well as lowered clinic systolic blood pressure considerably more than the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide at its highest approved dose.

Earlier clinical trials have demonstrated that chlorthalidone is effective in reducing blood pressure in patients with hypertension and that long-term use is associated with reducing serious hypertension-related complications.