Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved EDARBI (azilsartan medoxomil) for the treatment of hypertension, or high blood pressure, in adults. EDARBI is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone that constricts blood vessels. When the angiotensin II receptor is blocked, blood vessels stay relaxed and open and blood pressure can be reduced. EDARBI is approved as a once-daily oral therapy for use alone and for use in combination with other antihypertensive medications.

Takeda Global Research & Development Center, Inc. U.S. submitted a new drug application (NDA) for EDARBI in April 2010. The NDA was supported by seven controlled phase 3 clinical trials involving more than 5,900 patients with hypertension. Pivotal phase 3 studies showed EDARBI (80 mg/day) was statistically superior to placebo and the highest approved doses of two commonly prescribed ARBs, olmesartan medoxomil (40 mg/day) and valsartan (320 mg/day), in lowering both clinic and 24-hour mean blood pressure measurements.

"We are pleased to be able to build upon our global expertise in the cardiovascular therapeutic area with the approval of EDARBI in the U.S.," said Shinji Honda, president and CEO, Takeda Pharmaceuticals North America. "Through the discovery, development and commercialization of new medicines, Takeda is committed to bringing therapies like EDARBI to market. EDARBI is an important new treatment option for patients with hypertension and the health care professionals who treat them."

The safety and efficacy of EDARBI were studied as a once-daily oral therapy, as well as in combination with chlorthalidone and amlodipine. Results from the phase 3 clinical trials showed EDARBI successfully met the primary endpoint, change in 24-hour mean systolic blood pressure (SBP) as measured by Ambulatory Blood Pressure Monitoring, with statistical significance of lowering blood pressure compared to placebo and head-to-head active comparators. Specifically, results from one study showed EDARBI at doses of 80 mg/day and 40 mg/day lowered 24-hour mean SBP by 14.3 mm Hg and 13.2 mm Hg from baseline, respectively. The blood pressure reductions of EDARBI (80 mg/day) were statistically superior to those of the active comparators valsartan 320 mg/day (-10.0 mm Hg) and olmesartan medoxomil 40 mg/day (-11.7 mm Hg). Similar results were observed in all three comparator studies. The most common adverse reaction in adults was diarrhea (2%).