Takeda Launches Hypertension Tablets In Japan
Takeda Pharmaceutical announced that it has launched Zacras combination tablets, a fixed-dose combination (FDC) of azilsartan and amlodipine besylate hydrochloride, and Azilva tablets 10mg (azilsartan) for the treatment of hypertension in Japan.
Zacras is a once-daily, oral tablet in two strengths: Zacras Combination Tablets LD (20mg azilsartan / 2.5mg amlodipine) and Zacras Combination Tablets HD (20mg azilsartan / 5mg). Avilza 10 mg tablets adds another dosage strength to the already available Azilva 20 mg and 40 mg. Azilsartan is a angiotensin II receptor blocker (ARB) that works to lower blood pressure by blocking the vasopressor hormone angiotensin II. Amlodipine is a calcium channel blocker with a hypotensive action that inhibits inward calcium ion channels in the vascular smooth-muscle cells. This results in peripheral arteriolar vasodilation.
The company reports that in a Phase III clinical trial, Zacras’ anti-hypertensive effect in diastolic blood pressure was statistically significant versus monotherapy with either azilsartan or amlodipine. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH2014), issued by the Japanese Society of Hypertension, recommends the ARB-CCB combination treatment for hypertension based on safety and efficacy. Takeda points out that the simpler prescription of fixed dose combination also leads to improved blood pressure control. NHI prices of the FDC drugs are also comparatively lower than the sum of two individual drugs.
Masato Iwasaki, Director and Senior Vice President, Pharmaceutical Marketing Division of Takeda, said, “The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH2014) report that there are approximately 43 million hypertensive patients in Japan, and of all individuals on anti-hypertensive medication, only approximately 30% of men and 40% of women have achieved their target blood pressure 2 levels. We believe that Zacras, having strong and persistent hypotensive effects, may offer a new… optimal treatment option that fit the clinical conditions of individual patients.”