FDA Approves Edarbyclor®

By: Gokul Kalla, Pharm.D. Candidate c/o 2013

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Hypertension is a chronic disease that affects one out of every three Americans.  Leaving the condition untreated could increase the risk of serious health consequences such as a stroke or a heart attack.  On December 21, the FDA approved Takeda Pharmaceuticals’ Edarbyclor^® (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension in adults.  Edarbyclor^® is a combination of a fixed dose Angiotensin II Receptor Blocker (ARB), azilsartan medoxomil, and a thiazide diuretic, chlorthalidone.

Earlier in 2011, one of the main components of Edarbyclor^® (azilsartan) was marketed as Edarbi^®.  It works by blocking the action of Angiotensin II, a vasopressor hormone in the body that increases blood pressure.  As a diuretic, chlorthalidone reduces the body’s fluid volume by increasing urination.  The combination of these two medications resulted in a greater overall reduction of blood pressure in patients with chronic hypertension and a decrease in hypertension-related complications.

To assess the safety and efficacy of Edarbyclor^®, a 52-week, 5-phase clinical trial was conducted with 5,000 hypertensive patients.  The trial resulted in a lower mean trough systolic blood pressure (SBP) versus azilsartan medoxomil or chlorthalidone alone.  In addition, SBP was lower when compared against the highest fixed dose combination of olmesartan medoxomil and hydrochlorothiazide (Benicar-HCT^®) at its highest approved dose of 40/25 mg.

Although a “me-too” drug, Edarbyclor^® is promising for patients who suffer from chronic hypertension.  More trials are needed to justify its use over more inexpensive and efficacious alternatives in its class.

SOURCES:

• Takeda Pharmaceutical Company Limited. FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension. Available online: http://www.takeda.com/press/article_44059.html