FDA Approves Azilsartan, Another ARB, for Hypertension

February 25, 2011

February 25, 2011 (Updated February 28, 2011) (Silver Spring, Maryland) — The Food and Drug Administration (FDA) today approved a new angiotensin-receptor blocker (ARB), azilsartan medoxomil (Edarbi, Takeda Pharmaceutical), for the treatment of hypertension in adults [1]. The drug will be available in 80-mg and 40-mg doses, although 80 mg is the recommended dose. The 40-mg dose is available for clinicians who wish to combine the drug in patients treated with high-dose diuretic therapy.

In phase 3 studies, first reported by heartwire at the American Society of Hypertension (ASH) meeting in 2010, azilsartan at its highest dose was more effective in lowering 24-hour blood pressure than two of its ARB rivals, olmesartan (Benicar, Daiichi Sankyo) and valsartan (Diovan, Novartis).

Earlier this week, Takeda also submitted a new drug application (NDA) to the FDA for a tablet that combines azilsartan with chlorthalidone, a thiazidelike diuretic. In a trial also presented last year at ASH, the azilsartan-chlorthalidone combination had better antihypertensive effects than azilsartan and hydrochlorothiazide (HCTZ).

Azilsartan contains a boxed warning stating that it should be avoided in pregnant women, as it can cause injury to the developing fetus if taken by the mother in her second or third trimester. If a women taking azilsartan becomes pregnant, the drug should be stopped.