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

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Takeda Pharmaceutical Company Limited

08 Dec, 2011, 15:17 GMT

LONDON and OSAKA, Japan, December 8, 2011 /PRNewswire/ --

Takeda Pharmaceutical Company Limited (Takeda) today announced that the European Commission has granted marketing authorisation for Edarbi® (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® (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