London and Osaka, Japan (ots/PRNewswire) - Takeda
Pharmaceutical Company Limited (Takeda) today announced that Takeda
Global Research & Development Centre (Europe), Ltd. submitted a
Marketing Authorisation Application (MAA) for azilsartan medoxomil
(development code: TAK-491), an angiotensin II receptor blocker
(ARB), to the European Medicines Agency (EMA) for the treatment of
essential hypertension. The EMA has confirmed that the submission has
been validated for assessment.
High blood pressure, or hypertension, was responsible for 7.6
million preventable deaths worldwide in 2001.(1) Almost half (44
percent) of the adult population in Europe is affected by
hypertension - much (approximately 60 percent) higher than in the
United States and Canada.(2) Discovered by Takeda, azilsartan
medoxomil is a prodrug of the active moiety azilsartan, which lowers
blood pressure by blocking the action of a vasopressor hormone,
angiotensin II.(3) The discovery and development of azilsartan
medoxomil continues Takeda's commitment to the treatment of
hypertension, and builds upon the company's long-standing clinical
experience with its previously discovered antihypertensive agent
The MAA submission for azilsartan medoxomil monotherapy was
supported by positive results from a clinical development program
which included nine phase 3 clinical trials in which approximately
7000 subjects with essential hypertension were enrolled of whom 4814
unique subjects received at least 1 dose of azilsartan medoxomil.(4)
The safety and efficacy of azilsartan medoxomil was studied for
initial therapy as a once-daily oral monotherapy or for
co-administration with other antihypertensive medications, including
the diuretics chlorthalidone and hydrochlorothiazide, and the calcium
channel blocker, amlodipine.(5) It was also studied in comparison
with olmesartan medoxomil,(6) valsartan(6) and ramipril.(7)
Results from the phase 3 clinical trials showed azilsartan
medoxomil successfully met the primary endpoints: change in 24-hour
mean systolic blood pressure (SBP) by ambulatory blood pressure
monitoring (ABPM) and key secondary endpoint, clinic SBP, producing a
statistically significant and clinically meaningful lowering of blood
pressure in subjects with essential hypertension.(4) The most
commonly reported treatment-related adverse reactions in phase 3
monotherapy placebo-controlled clinical trials were dizziness,
increased blood creatine phosphokinase, diarrhoea, fatigue and
In April 2010, Takeda submitted a New Drug Application for
azilsartan medoxomil to the U.S. Food and Drug Administration. The
filing is currently under regulatory review.
"This MAA represents a significant milestone for our company and
carries positive clinical implications for both physicians and
patients for the treatment of essential hypertension," said Suhail
Nurbhai, M.D., vice president & head of Clinical Science, Takeda
Global Research & Development Centre (Europe), Ltd. "Based on the
encouraging results of phase 3 clinical studies demonstrating the
compound's efficacy, safety and tolerability, we believe azilsartan
medoxomil, once approved, will provide clinicians in Europe with an
important additional treatment for patients with essential
"Takeda is committed to developing treatments for patients with
cardiovascular disease and for use by healthcare providers for their
patients," said Steve Coles, Ph.D., managing director, Takeda Global
Research & Development Centre (Europe), Ltd. "We are proud to
continue expanding our cardiovascular expertise in Europe to
potentially address this serious health problem."
About Azilsartan Medoxomil
Discovered by Takeda, azilsartan medoxomil, also known as
TAK-491, is a prodrug of the active moiety azilsartan, which lowers
blood pressure by blocking the action of a vasopressor hormone,
angiotensin II, either when used alone or when co-administered with
other classes of antihypertensive agents.(4) Angiotensin II, a
vasopressor, is a hormone that naturally exists within the body and
plays a key role in cardiovascular function.(3) The hormone induces
contraction, or tightening, of blood vessels and thus plays an
important role in mediating hypertension.(3) The most commonly
reported treatment-related adverse reactions occurring at a higher
rate than placebo in phase 3 clinical trials (based on pooled data
[40 and 80 mg doses] from monotherapy placebo-controlled studies)
were dizziness (2.1%), increased blood creatine phosphokinase (1.1%),
diarrhoea (1.0%), fatigue (0.8%) and peripheral oedema (0.6%).(8)
About Takeda Global Research & Development Centre (Europe), Ltd.
Based in London, England, Takeda Global Research & Development
Centre (Europe), Ltd., (TGRD Europe), is a subsidiary of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in
Japan. TGRD Europe seeks to bring innovative products to patients
through a pipeline that includes compounds in development for
diabetes, cardiovascular disease, neurology, oncology and other
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,
(1) Lawes, C. M.M., et. al., Global Burden of
Blood-Pressure-Related Disease, 2001. The Lancet. 2008; 371: 1513-18.
(2) Wolf-Maier, K. et al. Hypertension Prevalence and Blood
Pressure Levels in 6 European Countries, Canada, and the United
States. Journal of the American Medical Association.
(3) Taubman, M. Angiotensin II. A Vasoactive Hormone With
Ever-Increasing Biological Roles. Circulation Research. 2003;92:9.
(4) Data on file.
(5) Weber, M. Antihypertensive Efficacy of the New Angiotensin
Receptor Blocker Azilsartan Medoxomil in Combination with Amlodipine.
The Journal of Clinical Hypertension. April 2010, Vol. 12. Suppl. 1.
(6) White, W., et. al. The New Angiotensin Azilsartan Medoxomil
Has Superior 24-Hour Blood Pressure Lowering Efficacy to Both
Olmesartan and Valsartan. The Journal of Clinical Hypertension.
April 2010, Vol. 12. Suppl. 1. A116.
(7) Bonner, G. Comparison of Antihypertensive Efficacy of the new
Angiotensin Receptor Blocker Azilsartan Medoxomil with Ramipril.
Abstract. Presented at European Society of Hypertension meeting, June
18-21 2010, in Oslo, Norway.
(8) Draft Azilsartan Medoxomil Summary of Product
Characteristics. Page 4. Table 1.
Takeda Pharmaceuticals, Inc.
Corporate Communications Dept.
Takeda Pharmaceutical Company Limited
Takeda Pharmaceuticals Europe Ltd
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