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news.Takeda Pharmaceutical has gained the US Food and Drug Administration (FDA) approval for its Edarbyclor (azilsartan medoxomil and chlorthalidone), used to treat hypertension in adults.
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Edarbyclor is a once-daily fixed-dose combination regimen of azilsartan medoxomil and diuretic chlorthalidone.
The recommended starting dose of Edarbyclor is 40/12.5 mg and the maximum dose is 40/25 mg.
Azilsartan medoxomil reduces blood pressure by blocking the action of angiotensin II, and chlorthalidone lowers blood pressure by reducing the amount of water in the body and increasing the flow of urine.
The five Phase 3 clinical studies have investigated 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 80/25 mg.
The studies demonstrated that Edarbyclor lowered mean trough systolic blood pressure (SBP), reduced blood pressure in black and non-black patients at similar levels, as well as lowered clinic SBP considerably more than the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide at its highest approved dose.
Takeda Pharmaceutical Medical & Scientific affairs executive medical director Paulos Berhanu said Edarbyclor showed significant blood pressure reductions and was found to be superior to the fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide at maximum respective doses.