Japan briefs: Takeda files for Azilva comb; Sandoz seeks filgrastim biosimilar approval

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) says that it submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan for a fixed-dose combination of Azilva (azilsartan) and amlodipine besylate tablets for treatment of hypertension.

Discovered by Takeda, Azilva is a potent and lasting angiotensin II receptor blocker (ARB) that lowers blood pressure by inhibiting the action of angiotensin II, a vasopressor hormone. Amlodipine besylate is a calcium channel blocker (CCB) having a hypotensive action by blocking inward calcium ion channels mainly in vascular smooth-muscle cells, resulting in peripheral arteriolar vasodilation.

Takeda conducted a multicenter, randomized, double-blind controlled Phase III clinical trial with 568 patients with grade I (mild) and II (moderate) hypertension, in which the efficacy and safety of a fixed dose of Azilva and amlodipine besylate were compared with monotherapy of either Azilva or amlodipine besylate. The anti-hypertensive effect in diastolic blood pressure in the sitting position as the primary endpoint, of the combination was statistically significant as compared to monotherapy with either one of the two drugs. The therapy was also demonstrated to have a safety and tolerability profile comparable to each of the monotherapies.