Edarbi

Treatment for Hypertension

Update: Edarbi (azilsartan medoxomil) Now FDA Approved - February 25, 2011

NDA Submitted for Azilsartan Medoxomil

Takeda Submits New Drug Application for Azilsartan Medoxomil in the U.S., an Investigational Compound for the Treatment of Hypertension

DEERFIELD, Ill. and OSAKA, Japan, April 27 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension. Discovered by Takeda, azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.

"The NDA submission for azilsartan medoxomil is built upon a robust data package and is a significant milestone for Takeda," said Nancy Joseph-Ridge, M.D., general manager of Takeda's Pharmaceutical Development Division. "We are proud to build upon our global expertise in the cardiovascular therapeutic area with this filing, and believe this compound, once approved, will provide an important treatment option for hypertensive patients and the health care providers who manage them."

The NDA submission was supported by seven phase 3 clinical trials involving more than 5,900 patients. The safety and efficacy of azilsartan medoxomil was studied for initial therapy as a once-daily oral monotherapy or in combination with other antihypertensive medications, including chlorthalidone and amlodipine, and was also studied in comparison to olmesartan medoxomil, valsartan and ramipril. Results from five of the pivotal phase 3 studies will be presented May 1-4, 2010, at the American Society of Hypertension Inc. (ASH), 25th Annual Scientific Meeting and Exposition in New York.

About Hypertension

High blood pressure, or hypertension, impacts approximately 75 million Americans and is the second-leading preventable risk factor for death in the U.S. Hypertension is defined as elevated blood pressure 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. Approximately 56 percent of all hypertension patients, or approximately 42 million Americans, still have uncontrolled hypertension despite current treatment options, or due to a lack of being diagnosed or treated. Hypertension can lead to serious or fatal health problems. Earlier this year, the Institute of Medicine issued a report calling hypertension a "neglected disease" because it is treatable and yet widely prevalent. High blood pressure often has no warning signs or symptoms, and many people don't realize they have it. People of all ages and backgrounds can develop hypertension, and the National Heart Lung and Blood Institute recommends blood pressure be checked every two years and that people with hypertension should check their blood pressure levels several times a year.

About Azilsartan Medoxomil

Discovered by Takeda, azilsartan medoxomil, also known as TAK-491, is an angiotensin II receptor blocker currently in development for the treatment of hypertension, or high blood pressure, either used alone or in combination with other classes of antihypertensive agents. Angiotensin II, a vasopressor, is a hormone that naturally exists within the body and plays a key role in cardiovascular function. The hormone induces contraction, or tightening, of blood vessels and thus plays an important role in mediating hypertension. The most commonly reported treatment-related adverse reactions (>/=1%) in phase 3 clinical trials were dizziness (2.1%), increased blood creatine phosphokinase (1.1%) and diarrhea (1.0%).

About 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 and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, 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 striving toward better health for individuals and progress in medicine. Additional information about Takeda is available through its corporate Web site, www.takeda.com.

Source: Takeda Pharmaceutical Company Limited; Takeda Global Research & Development Center, Inc., U.S.

CONTACT: Julia Ellwanger of Takeda Global Research & Development,
+1-224-554-7681, julia.ellwanger@tpna.com; or Elissa J. Johnsen of Takeda
Pharmaceuticals North America, +1-224-554-3185, ejohnsen@tpna.com; or
Corporate Communications Dept. of Takeda Pharmaceutical Company Limited,
+81-3-3278-2037

Web Site: http://www.takeda.com/
http://www.tpna.com/

Posted: April 2010

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