FDA Approves Daiichi’s Hypertension Combo Product

Daiichi Sankyo received FDA approval of Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide), a new three-in-one combination drug taken once-daily for the treatment of hypertension in patients who are not adequately controlled with other antihypertensive drug classes including: angiotensin receptor blockers, calcium channel blockers and diuretics.

Tribenzor combines three widely prescribed antihypertensive medications, each working in a different way, to lower blood pressure. It combines olmesartan medoxomil (which blocks angiotensin II receptors), amlodipine (which inhibits the entrance of calcium into the blood vessel walls), and hydrochlorothiazide (a diuretic which reduces water volume in the blood).

After eight weeks of treatment, Tribenzor produced statistically significant reductions in both systolic and diastolic blood pressures compared to each of the three dual combination therapies. The trial included 2,492 patients with hypertension.