Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that EDARBI (azilsartan medoxomil), an angiotensin II receptor blocker (ARB) approved for the treatment of hypertension, or high blood pressure, is now available by prescription for adults in US pharmacies.

The US Food and Drug Administration (FDA) approved EDARBI on February 25, 2011 as a once-daily oral therapy for use alone and for use in combination with other antihypertensive medications. Pivotal phase 3 studies showed EDARBI (80 mg/day) was statistically superior to the highest approved doses of two commonly prescribed ARBs, olmesartan medoxomil (40 mg/day) and valsartan (320 mg/day), in lowering both clinic systolic blood pressure (SBP) and 24-hour mean SBP as measured by Ambulatory Blood Pressure Monitoring (ABPM).

Takeda also announced that the FDA approved updated product labelling for EDARBI, which highlights the connection between lowering blood pressure and decreased risks of cardiovascular outcomes, including strokes and heart attacks. The new product label reflects FDA guidance released in March 2011 for manufacturers of all anti-hypertensive treatments. The guidance stated, “blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem.”

“Hypertension is a serious condition but typically does not have any symptoms, and many aren’t aware of the long-term impact hypertension has on cardiovascular health,” said Paulos Berhanu, M.D., executive medical director of medical & scientific affairs, Takeda Pharmaceuticals North America. “We are pleased to make available EDARBI, an important new treatment option for patients with hypertension and the healthcare professionals who treat them.”

Developed by Takeda, EDARBI is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension to lower blood pressure in adults. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBI. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

EDARBI may be used either alone or in combination with other anti-hypertensive agents. The recommended dose of EDARBI in adults is 80 mg taken once daily. A starting dose of 40 mg may be appropriate for patients on high doses of diuretics. EDARBI lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone, which naturally exists within the body. When EDARBI blocks the angiotensin II receptor, blood vessels can stay relaxed and open and blood pressure can be reduced.

Results from the phase 3 clinical trials showed EDARBI successfully met the primary endpoint, change in 24-hour mean SBP as measured by ABPM, 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).

Based in Deerfield, Illinois, Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions.