Daiichi Sankyo files NDA for combo CV drug

Japanese drugmaker Daiichi Sankyo has filed a New Drug Application with the US Food and Drug Administration for a fixed-dose combination of two antihypertensives, its angiotensin-receptor blocker Benicar (olmesartan medoxomil), together with Pfizer's calcium channel blocker Norvasc (amlodipine besylate).

Pending approval, the combination will be indicated for the treatment of hypertension and may be used either alone or in combination with other antihypertensive agents.

According to the Japanese firm, in a clinical trial, the combination of the two drugs demonstrated clinically-significant mean blood pressure reductions, which is unsurprising given that it utilizes two complementary mechanisms of action: calcium channel blockade and angiotensin II receptor blockade. Benicar is the fastest-growing medication in the fastest-growing class of blood pressure-lowering drugs, while Norvasc is the most widely-used CCB on the market, according to Daiichi Sankyo press statement.