Takeda’s Edarbi® (azilsartan medoxomil) receives European marketing authorisation for the treatment of essential hypertension

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.”

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]