Takeda Pharmaceutical Company Limited

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/Summary_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/GlobalHealthRisks_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 robert.gallo@tpeu.co.uk Victoria Boswell-Smith Virgo HEALTH +44-208-939-2458 Victoria.boswell-smith@virgohealth.com

Contact:

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