Takeda's Edarbi® (azilsartan medoxomil) Receives European Marketing Authorisation for the Treatment of Essential Hypertension

London and Osaka, Japan (ots/PRNewswire) -

Takeda Pharmaceutical Company Limited (Takeda) today announced
that the European Commission has granted marketing authorisation for
Edarbi(R) (azilsartan medoxomil), a new once-daily angiotensin
receptor blocker (ARB) (also known as angiotensin II receptor
antagonist [AIIRA]) for the treatment of essential hypertension (high
blood pressure) in adults.[1]

Takeda will launch azilsartan medoxomil across Europe in 2012
starting with Germany in January.

"The marketing authorisation for azilsartan medoxomil marks an
important milestone for Takeda, building on our 30-year heritage in
cardiovascular disease and reinforcing our commitment to expand the
boundaries of hypertension treatment, address unmet needs and
ultimately optimise patient outcomes across Europe," said Trevor
Smith, Head of Europe and Canada. "We believe azilsartan medoxomil
provides clinicians with a highly effective new option for patients
with essential hypertension."

The marketing authorisation follows a positive opinion from the
Committee for Human Medicinal Products (CHMP) based on the results
from an extensive pre-clinical and clinical development programme,
including seven phase III clinical trials involving nearly 6,000
patients with essential hypertension.[2,3] Pivotal phase III studies
showed that the highest approved dose of azilsartan medoxomil
(80mg/day) resulted in significantly greater reductions in mean
24-hour and clinic systolic blood pressure than the highest approved
doses of the ARBs olmesartan medoxomil (40mg/day)[4,5], valsartan
(320mg/day)[4,6] and the ACE inhibitor ramipril (10mg/day)[7]. In
clinical studies, adverse reactions associated with treatment with
azilsartan medoxomil were mostly mild or moderate, with an overall
incidence similar to placebo.[8] The most commonly observed
treatment-related adverse reactions were dizziness, increased blood
creatine phosphokinase and diarrhoea.[3]

"We have been treating hypertension for decades with numerous
different treatment regimens, yet achieving sufficient 24 hour blood
pressure control, with the associated beneficial effects on
cardiovascular morbidity and mortality still remains a challenge,"
says Professor Neil Poulter, Professor of Preventive Cardiovascular
Medicine, National Heart and Lung Institute at Imperial College
London. "Any new treatment option that can improve effective BP
control will be well received, and will help to reduce the huge
health burden due to the adverse effects on cardiovascular events
which raised BP currently causes."

Notes to Editors

About Edarbi(R) (azilsartan medoxomil)

- Azilsartan medoxomil is an angiotensin receptor blocker 
(ARB) (also known
          as angiotensin II receptor antagonist [AIIRA]) developed by
Takeda for the treatment
          of high blood pressure in adults[3]
        - Azilsartan medoxomil either when used alone or when 
co-administered with other
          classes of antihypertensive agents[3] lowers blood pressure
by blocking the action of
          the hormone angiotensin II, a hormone which is generated by
the activation of the
          renin-angiotensin-aldosterone system (RAAS), one of the 
major blood pressure
          regulating systems.
        - Angiotensin II, a hormone that naturally exists within the 
body, induces
          contraction, or tightening, of blood vessels and thus plays
an important role in
          mediating hypertension[8]
        - Azilsartan medoxomil has also been further tested in two 
long term open label
          studies, bringing the total number of phase III studies to 
nine involving over 7,000
          patients with essential hypertension

About high blood pressure (essential hypertension)

- High blood pressure, or hypertension, is a chronic medical 
condition in
          which clinic blood pressure is elevated to levels of 
140mmHg or greater systolic or
          90mmHg or greater diastolic[9]
        - Almost half (44%) of the adult population in Europe is 
affected by high blood
          pressure[10]
        - High blood pressure was responsible for 7.5 million 
preventable deaths
          worldwide in 2004[11]
        - High blood pressure typically has no symptoms.[10] Although
it can affect
          adults of any age, the risk of developing the condition 
increases with age, with more
          than half of people over 60 affected [10]

References

1) European Commission. Available at: 
http://ec.europa.eu/index_en.htm
          [Last accessed December 2011]
        2) EMA. Summary of opinion. 2011. Available at :
          http://www.ema.europa.eu/docs/en_GB/document_library/Summar
y_of_opinion_-_Initial_authorisation/human/002293/WC500112771.pdf
          [Last accessed October 2011]
        3) Azilsartan medoxomil Summary of Product Characteristics.
        4) White WB, Weber MA, Sica D, et al. Effects of the 
angiotensin receptor
          blocker azilsartan medoxomil versus olmesartan and 
valsartan on ambulatory and clinic
          blood pressure in patients with stages 1 and 2 
hypertension. Hypertension. 2011;
          57(3):413-20
        5) Bakris GL, Sica D, Weber M, et al. The comparative effects
of azilsartan
          medoxomil and olmesartan on ambulatory and clinic blood 
pressure. The Journal of
          Clinical Hypertension. 2011; 13(2):81-88
        6) Sica D, White WB, Weber MA. Comparison of the novel 
angiotensin II receptor
          blocker azilsartan medoxomil vs valsartan by ambulatory 
blood pressure monitoring. The
          Journal of Clinical Hypertension. 2011; 13:467-472
        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, 18-21 2010, Oslo, Norway
        8) Taubman, M. Angiotensin II. A vasoactive hormone with 
ever-increasing
          biological roles. Circulation Research. 2003; 92:9
        9) NICE clinical guideline 127. Hypertension: Clinical 
management of primary
          hypertension in adults. Available from:
          http://www.nice.org.uk/nicemedia/live/13561/56008/56008.pdf
[Last accessed
          November 2011]
          10) Wolf-Maier K, Cooper RS, Banegas JR, et al. 
Hypertension prevalence and
          blood pressure levels in 6 European countries, Canada, and 
the United States. Journal
          of the American Medical Association. 2003; 
289(18):2363-2369
          11) WHO. Global health risks: Mortality and burden of 
disease attributable to
          selected major risks. 2009. Available at:
          http://www.who.int/healthinfo/global_burden_disease/GlobalH
ealthRisks_report_full.pdf
          [Last accessed September 2011]

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,
http://www.takeda.com.

About Takeda Pharmaceuticals Europe

Based in London, Takeda Pharmaceuticals Europe leads the overall
business activities of Takeda's European subsidiaries ("TES"),
providing strategic direction and management support across the
region.

Contacts Takeda Pharmaceutical Company Limited
Corporate Communications Dept. +81-3-3278-2037 Takeda
Pharmaceuticals Europe Ltd Rob Gallo +44-203-116-8874
[email protected] Victoria Boswell-Smith Virgo
HEALTH +44-208-939-2458
[email protected]

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