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Zacras® Combination Tablets LD and Zacras® Combination Tablets HD, Fixed-Dose Combination of Azilsartan and Amlodipine, and Azilva® Tablets 10mg, Treatment for Hypertension, are Now Available in Japan

June 18, 2014

Osaka, Japan, June 18, 2014— Takeda Pharmaceutical Company Limited (“Takeda”) announced today that Zacras® combination tablets, a fixed-dose combination ("FDC") of azilsartan (generic name) and amlodipine besylate hydrochloride (generic name, "amlodipine"), and Azilva® tablets 10mg (generic name: azilsartan) are now available for treatment of hypertension in Japan.

Zacras is a tablet administrated orally once daily and has two dosage strengths, “Zacras® Combination Tablets LD” and “Zacras® Combination Tablets HD” which contain 20mg azilsartan / 2.5mg amlodipine, and 20mg azilsartan / 5mg amlodipine respectively. Azilva tablets 10 mg is the addition of a new dosage strength to already-marketed Azilva Tablets 20mg and 40 mg.

Discovered 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. Amlodipine 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. In a phase 3 clinical trial, the anti-hypertensive effect in diastolic blood pressure in the sitting position as the primary endpoint, of Zacras was statistically significant compared to monotherapy with either azilsartan or amlodipine.

The ARB-CCB combination 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 (JSH2014), issued by the Japanese Society of Hypertension, from the standpoint of safety and efficacy. Simpler prescription using the FDC will improve adherence*, leading to improved blood pressure control. Furthermore, the NHI Prices of the FDC are set lower than the sum of the two individual drugs. This may positively impact healthcare costs.

”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 levels**. We believe that Zacras, having strong and persistent hypotensive effects, may offer a new treatment option," said Masato Iwasaki, Ph.D., Director and Senior Vice President, Pharmaceutical Marketing Division of Takeda. "With our anti-hypertensive medications including this wider range of the azilsartan family, Takeda will continue contributing to the treatment of the disease by proposing optimal treatment options that fit the clinical conditions of individual patients.”

*Patients actively participate in the decision-making of treatment courses or policies, and the treatment is implemented and continued accordingly.
** Systolic blood pressure is under 140mmHg and diastolic blood pressure is under 90mmHg.


About Zacras® Combination Tablets
Japanese Brand Name Zacras® Combination Tablets LD and Zacras® Combination Tablets HD
Generic Name Azilsartan / Amlodipine besylate hydrochloride
Dosage and Administration For adults, a tablet, 20mg azilsartan / 2.5mg amlodipine, or 20mg azilsartan / 5mg amlodipine, is orally administered once a day. It is not able to be used for the first line treatment of hypertension.
Indication Hypertension
NHI Price Zacras® Combination Tablets LD: ¥140.60
Zacras® Combination Tablets HD: ¥140.60


NHI Price of Azilva® Tablets 10mg: ¥93.60