April 27, 2010
Takeda Submits New Drug Application for Azilsartan Medoxomil in the U.S., an Investigational Compound for the
Treatment of Hypertension
Deerfield, Ill., April 27, 2010, and Osaka, Japan, April 28, 2010 – 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.
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Contacts:
Julia Ellwanger
Takeda Global Research & Development
224-554-7681
julia.ellwanger@tpna.com
Corporate Communications Dept.
Takeda Pharmaceutical Company Limited
+81-3-3278-2037
Elissa J. Johnsen
Takeda Pharmaceuticals North America
224-554-3185
ejohnsen@tpna.com