Navigation Links
EDARBI (azilsartan medoxomil), Now Available in U.S. Pharmacies for Patients With Hypertension
Date:4/14/2011

DEERFIELD, Ill. and OSAKA, Japan, April 15, 2011 /PRNewswire/ -- 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."

About HypertensionHypertension, 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.

About EDARBI 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 InformationBoxed Warning: Avoid Use in PregnancyWhen 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 LimitedLocated 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.Contacts:Ashleigh Duchene

Elissa J. JohnsenGolinHarris

Takeda Pharmaceuticals North America312-729-4428

224-554-3185aduchene@golinharris.com

ejohnsen@tpna.comCorporate Communications Dept.Takeda Pharmaceutical Company Limited+81-3-3278-2037
'/>"/>

SOURCE Takeda Pharmaceuticals North America, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Edarbi to Treat High Blood Pressure
2. FDA Approves EDARBI (azilsartan medoxomil) for the Treatment of Hypertension
3. The Next Generation in Bilevel Therapy Now Available on ResMeds Award-Winning S9™ Platform
4. Affordable Nerve Pain Treatment Now Available in the U.S.
5. ABSTRAL® (fentanyl) Sublingual Tablets CII, First-in-class, Sublingual, Immediate Release Opioid for Managing Breakthrough Cancer Pain, Now Available in the U.S.
6. Axiron® (Testosterone) Topical Solution CIII Now Available in Pharmacies
7. Songbird® Hearing Launches the Worlds First High-Quality, Low-Cost Sound Enhancement Product Available at Retail
8. New Acetadote® Formulation Now Available in the U.S.
9. Video from Novo Nordisk A/S available on thenewsmarket.com: Novo Nordisk Receives Approval for Victoza in China
10. Allon Therapeutics CEO Presentation Now Available for On-Demand Viewing at RetailInvestorConferences.com
11. Delta National Excellence in Therapy Report Now Available
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... February 23, 2017 Obese people ... caseload for varicose veins in their body. The rising ... prompting the adoption of endovenous laser therapy for treatment ... endovenous laser therapy market, published by Future Market ... choices and consequences of obesity have collectively factored the ...
(Date:2/23/2017)... February 23, 2017 The fast-growing cannabis ... the United States . According to the 2017 Legal ... is expected to create 283,422 jobs by 2020, with an ... the next four years. The accelerating pace of cannabis legalization ... of legal cannabis market, which will further create more business ...
(Date:2/23/2017)... February 23, 2017 The top ... are GE Healthcare, Koninklijke Philips N.V., and Schiller. Collectively, ... the global market in 2015. Strong product portfolio and ... assessed to be aiding these players remain leaders in ... the players in the global market are likely to ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... The International Association of ... “Imagine Me Beyond What You See” body image mannequin art competition. Selected from 15 ... showcased and the winner revealed at the 31st annual iaedp Symposium, March 22 – ...
(Date:2/24/2017)... ... February 24, 2017 , ... Congratulations to Head Over Heels’ ... February 12th. Ms. Esparza qualified into this prestigious status after winning the ... Las Vegas, Nevada. Frida is one of approximately 25 gymnasts in the nation ...
(Date:2/23/2017)... ... February 23, 2017 , ... The 89th Academy Awards ... of the 2016 National Education Policy Center Bunkum Award. We invite you to enjoy ... , This year’s Bunkum winner is the Center for American Progress (CAP), for its ...
(Date:2/23/2017)... ... February 23, 2017 , ... Los Angeles-based weight loss surgeon ... TV’s “Mama June: From Not to Hot,” which will begin airing on February 24, ... known to millions from the 2012 reality television series, “Here Comes Honey Boo Boo.” ...
(Date:2/23/2017)... Los Angeles, California (PRWEB) , ... February 23, ... ... for Global Sports Development will host a diverse symposium on “Doping ... School of Law and Sheppard Mullin Richter & Hampton LLP. The symposium will ...
Breaking Medicine News(10 mins):