Updated label reflects new FDA guidance on the association between decreased blood pressure and improved cardiovascular outcomes
Deerfield, Ill., and Osaka, Japan, April 15, 2011 – Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today 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 U.S. pharmacies. The U.S. 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 labeling 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 antihypertensive 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.”
Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated at levels of 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Hypertension impacts approximately 75 million Americans, or nearly one in three adults. It is estimated that nearly one billion people are affected by hypertension worldwide, and this figure is predicted to increase to 1.5 billion by 2025. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected. Hypertension is also costly to the nation’s health care system. The American Heart Association recently estimated that direct and indirect expenses associated with hypertension cost the nation more than $73 billion in 2009.
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 antihypertensive 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).
Important Safety Information
Boxed Warning: Avoid Use in Pregnancy
When pregnancy is detected, discontinue EDARBI as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Avoid fetal or neonatal exposure. Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women during the second and third trimester. Nursing mothers should discontinue either nursing or EDARBI.
Correct volume or salt depletion prior to administration of EDARBI. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with EDARBI.
Monitor for worsening renal function in patients with renal impairment. In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with ACE inhibitors and ARBs has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. Similar results may be anticipated in patients treated with EDARBI. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. There has been no long-term use of EDARBI in these patients but similar results may be expected.
Monitor renal function periodically in patients receiving EDARBI and NSAIDs who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function due to potential reversible deterioration of renal function.
Small reversible increases in serum creatinine are seen in patients receiving 80 mg of EDARBI. The increase may be larger when co-administered with chlorthalidone or hydrochlorothiazide. In addition, patients taking EDARBI who had moderate to severe renal impairment at baseline or those 75 years of age or older were more likely to report serum creatinine increases.
The most common adverse reaction that occurred more frequently with EDARBI than placebo in adults was diarrhea (two percent versus 0.5 percent).
Please click here for complete Prescribing Information, including boxed warning.
Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., 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. To learn more about these Takeda companies, visit www.tpna.com.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
Elissa J. Johnsen
Takeda Pharmaceuticals North America
Corporate Communications Dept.
Takeda Pharmaceutical Company Limited