US FDA approves Daiichi Sankyo's combo hypertensive Tribenzor; J&J's Tibotec files rilpivirine NDA

The US Food and Drug Administration yesterday approved Japanese drug major Daiichi Sankyo's Tribenzor (olmesartan medoxomil, amlodipine and hydrochlorothiazide), a new three-in-one combination product taken once-daily for the treatment of hypertension in patients who are not adequately controlled on any two of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers and diuretics. The new drug is not indicated for initial therapy.

Around 56% of patients taking current blood pressure-lowering therapies do not reach current recommended blood pressure goal of <140/90 mm hg or ><130/80 mm hg for patients with diabetes, chronic renal disease, or chronic cardiovascular disease. more than two-thirds of patients with high blood pressure will require two or more antihypertensive medications in order to achieve goal blood pressure control, according to the company.>

As a fixed-dose combination, Tribenzor simplifies dosing regimens, reduces pill burden and has the potential to lower co-pays for patients that require three medications to keep blood pressure within recommended levels, said Daiichi Sankyo. Research also shows that the use of fixed-dose antihypertensive combination treatments may improve patient compliance as compared to taking each medication separately, it added.