FDA approved Takeda’s Edarbyclor® (azilsartan medoxomil [Edarbi®] plus chlorthalidone) for the treatment of hypertension in adults. The firm says the fixed-dose single pill is the first combination of angiotensin II receptor blocker (ARB) with the diuretic chlorthalidone to be approved by FDA as a once-daily, single tablet.
Approval of Edarbyclor in the U.S. was based on data from five Phase III clinical studies involving over 5,000 hypertensive patients. The results demonstrated that the treatment lowered systolic blood pressure by a significantly greater amount than the fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide at its highest approved dose.
Takeda’s FDA-sanctioned antihypertensive drug Edarbi is available in the U.S. and Mexico, and was recently approved by the European regulatory authorities.