The Japanese Ministry of Health, Labour and Welfare has approved Takeda Pharmaceutical‘s new drug application (NDA) of Zacras tablets, a fixed-dose combination (FDC) of azilsartan (generic name) and amlodipine besylate hydrochloride (generic name, amlodipine), for treatment of hypertension.
The once-daily orally administered tablet, Zacras, has two dosage strengths, ‘Zacras Combination Tablets LD’, containing 20mg azilsartan / 2.5mg amlodipine, and ‘Zacras Combination Tablets HD’, which contain 20mg amlodipine / 5mg amlodipine.
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By GlobalDataDiscovered by Takeda, Azilsartan is a potent and lasting angiotensin II receptor blocker (ARB) that lowers blood pressure by inhibiting the action of angiotensin II, a vasopressor hormone.
The company said that amlodipine is a calcium channel blocker (CCB) that has a hypotensive action, which blocks inward calcium ion channels mainly in vascular smooth-muscle cells, resulting in peripheral arteriolar vasodilation.
The combination of ARB-CCB is one of the recommended treatments regimens as a combination therapy for the hypertension in the Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH2009), issued by the Japanese Society of Hypertension, for safety and efficacy.
NDA approval was based on results of multi-centre, randomised, double-blind controlled Phase III clinical trials carried out in Japan.
A total of 603 patients with grade I (mild) and II (moderate) hypertension were part of the Phase III clinical trial that involved efficacy and safety of an FDC of azilsartan and amlodipine being compared with monotherapy of either azilsartan or amlodipine.
Results showed that the anti-hypertensive effect in diastolic blood pressure in the sitting position as the primary endpoint, of the FDC of azilsartan and amlodipine was statistically significant compared with monotherapy with either monotherapy of the two drugs.
FDC therapy also showed safety and tolerability profile compared with each of the monotherapies.
Image: Micrograph showing a plexiform lesion of the lung, as seen in irreversible pulmonary hypertension. Photo: courtesy of Bulent Celasun.
