Takeda announced that the FDA has approved Edarbyclor (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension in adults. This approval was based on results from a clinical program consisting of five Phase 3 clinical studies involving more than 5,000 patients with hypertension. The studies demonstrated that Edarbyclor lowered mean trough (22–24 hours) systolic blood pressure by Ambulatory Blood Pressure Monitoring significantly more than either azilsartan medoxomil or chlorthalidone alone, lowered blood pressure in black and non-black patients at similar levels, and lowered clinic SBP significantly more than the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide at its highest approved dose (40/25mg doses for both medications).
Edarbyclor is a fixed-dose combination of an angiotensin II receptor blocker and diuretic. It will be available in 40/12.5mg and 40/25mg dosage strength tablets.
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