For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, President and CEO
(Code no.: 4568, First Section of Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Toshiaki Sai, Corporate Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126 (Public Relations)
+81-3-6225-1125 (Investor Relations)
http://www.daiichisankyo.com/
Daiichi Sankyo Announces First European Approval for Sevikar HCT(R), a New Three-in-one Combination Product for the Treatment of High Blood Pressure*
New Treatment Option Contributes to Fight Against Hypertension, Which Affects over 30% of Adults in Europe1
Munich, 20 December 2010 – Daiichi Sankyo Europe announced today that Sevikar HCT® is now approved in Germany, the first market to launch this new once-daily three-in-one combination product for the treatment of high blood pressure (BP). This new drug combines the three widely prescribed blood pressure treatments - olmesartan medoxomil, amlodipine, and hydrochlorothiazide (HCT) - in one single pill to help effectively control hypertension.2
The approval of Sevikar HCT® in Germany was granted after the European decentralised procedure was closed with a positive recommendation on the drug.
With the approval of Sevikar HCT®, Daiichi Sankyo offers physicians a comprehensive range of olmesartan based therapies to help them to successfully treat their patients to the accepted target blood pressure of less than 140/90 mmHg.
*Sevikar HCT® is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation (hydrochlorothiazide or amlodipine).3
“The approval for Sevikar HCT® is good news for both patients and physicians in Europe,” said Reinhard Bauer, CEO of Daiichi Sankyo Europe, “With olmesartan as the foundation for this new treatment option, we are confident that Sevikar HCT® will provide doctors with an additional therapy option to successfully treat their patients to blood pressure targets.”
Evidence shows that up to two-thirds of hypertensive patients require multiple medications from different classes of treatment, and many need three or more to reach the accepted blood pressure goal of 140/90 mmHg.4,5,6 The fixed-dose combination therapy Sevikar HCT® will provide doctors with a new treatment option to prescribe to patients, that simplifies treatment, provides patients with a more convenient option and decreases overall pill burden. Giving drugs as a single-pill fixed dose combination significantly improves compliance, and favors BP control compared with the same drugs given separately as two or more pills.7
The approval Sevikar HCT® completes the Daiichi Sankyo portfolio for the treatment of high blood pressure. The portfolio includes:
- Olmetec® (olmesartan medoxomil)
- Olmetec Plus® ▼(olmesartan + hydrochlorothiazide)
- Sevikar® ▼(olmesartan + amlodipine)
- Sevikar HCT® (olmesartan + amlodipine + hydrochlorothiazide)
About hypertension
Hypertension is one of the most prevalent conditions in Europe affecting approximately one in three adults and approximately one billion people worldwide.8 It is often challenging to control, and of those diagnosed with high blood pressure, approximately 65 percent do not have the condition under control.9
High blood pressure can cause permanent changes to blood vessels and the heart that may create serious problems elsewhere in the body. We know that tight BP control, as opposed to settling for treating patients to 5-10 mmHg above goal, can make a great deal of difference, reducing incidence of stroke by an impressive 44% and deaths by 32%.10
References
1 Kearney PM, et al. Kearney PM, Whelton M, Reynolds K, et al. Worldwide prevalence of hypertension: a systematic review. J Hypertens 2004;22:11-19
2 Oparil S, Melino M, Lee J, Fernandez V and Heyrman R. Triple therapy with Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in adult patients with hypertension: The TRINITY multicenter, randomized, double-bline, 12-week, parallel-group study. Clin Ther 2010: 32(7); 1252-1269
3Fachinformation Sevikar® HCT, Stand: Dezember 2010
4 National High Blood Pressure Education Program, JNC 7: The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure, December, 2003.
5 Cushman WC, et al. Success and predictors of blood pressure control in diverse North Am settings: the antihypertensive and lipid lowering treatment to prevent heart attack trial(ALLHAT). J Clin Hypertens (Greenwich). 2002;4:393– 404.
6 Hansson L, et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet 1998;351(9118):1755-62.
7Mancia, G., et al. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens;2009. 27: 2121-2158.
8Gupta AK, Arshad S and Poulter NR. Compliance, safety, and effectiveness of fixed-dos combinations of antihypertensive agents: a meta-analysis. Hypertension 2010:55(2); 399-407
9Kearney PM, Whelton M, Reynolds K, et al. Worldwide prevalence of hypertension: a systematic review. J Hypertens 2004;22:11-19
10Bakris, et al. Preserving renal function in Adults with Hypertension and Diabetes: A consensus approach. Am J Kidney Dis, 2000;36(3):646-661
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