Takeda receives positive CHMP opinion in Europe for EdarbiTM (azilsartan medoxomil)

Takeda Pharmaceutical Company Limited (Takeda) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for EdarbiTM (azilsartan medoxomil, development code: TAK-491), a new once-daily angiotensin II receptor antagonist (AIIRA) (also known as angiotensin receptor blocker [ARB]), for the treatment of essential hypertension (high blood pressure).1

“With almost half of the adult population in Europe affected by high blood pressure, this positive opinion for azilsartan medoxomil means there is a new option for patients,” said Trevor Smith, CEO, Takeda Pharmaceuticals Europe. “Building on our long heritage in cardiovascular disease the forthcoming launch of azilsartan medoxomil reinforces our commitment to expanding the boundaries of hypertension treatment across Europe”.

The CHMP opinion was based on data from nine phase 3 clinical trials, involving nearly 7000 patients with hypertension.2 Pivotal phase 3 studies showed that the highest approved dose of azilsartan medoxomil (80mg/day) resulted in significantly greater reductions in systolic blood pressure than the highest approved doses of olmesartan medoxomil (40mg/day)3,4 and valsartan (320mg/day)3,5 and the ACE inhibitor ramipril (10mg/day)6 in lowering both clinic and 24-hour mean blood pressure measurements. In clinical studies, adverse reactions associated with treatment with azilsartan medoxomil were mostly mild or moderate, with an overall incidence similar to placebo.7 The most commonly observed treatment-related adverse reactions are dizziness and increased blood creatine phosphokinase and diarrhoea.7

“Although there are many treatment options available to help manage hypertension, we know that many patients struggle to achieve clinically relevant blood pressure reduction that is maintained over a long term,” commented Prof. Dr. Roland E. Schmieder, Professor of Internal Medicine, University Hospital Erlangen, Germany. “Any new medication which can help patients achieve even just an additional 2mmHg reduction of blood pressure, which we already know can make a clinical difference, will always be welcome.”

References

1. EMA. Available at : http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002293/WC500112771.pdf [Last accessed September 2011]
2. Data on file
3. 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
4. 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
5. 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
6. 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
7. Azilsartan medoxomil Summary of Product Characteristics.
8. Taubman, M. Angiotensin II. A vasoactive hormone with ever-increasing biological roles. Circulation Research. 2003; 92:9
9. British Heart Foundation. Blood pressure. Available at: http://www.bhf.org.uk/heart-health/conditions/high-blood-pressure.aspx [Last accessed August 2011]
10. 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. 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]