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Daiichi Sankyo Announces First European Approval for Sevikar HCT(R), a New Three-in-one Combination Product for the Treatment of High Blood Pressure*

Munich (ots/PRNewswire)

Daiichi Sankyo Europe
announced today that Sevikar HCT(R) 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(R) in Germany was granted after the
European decentralised procedure was closed with a positive
recommendation on the drug.
With the approval of Sevikar HCT(R), 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(R) 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(R) 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(R) 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(R)
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(R) completes the Daiichi Sankyo
portfolio for the treatment of high blood pressure. The portfolio
includes:
  • Olmetec(R) (olmesartan medoxomil)
  • Olmetec Plus(R) q (olmesartan + hydrochlorothiazide)
  • Sevikar(R) q (olmesartan + amlodipine)
  • Sevikar HCT(R) (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)
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply
of innovative pharmaceutical products to address the diversified,
unmet medical needs of patients in both mature and emerging markets.
While maintaining its portfolio of marketed pharmaceuticals for
hypertension, hyperlipidemia, and bacterial infections, the Group is
engaged in the development of treatments for thrombotic disorders and
focused on the discovery of novel oncology and
cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo
Group has created a "Hybrid Business Model," which will respond to
market and customer diversity and optimise growth opportunities
across the value chain. For more information, please visit:
http://www.daiichisankyo.com.
The company's world headquarters are in Tokyo. Its European base
is located in Munich. DAIICHI SANKYO EUROPE has affiliates in 12
European countries in addition to a global manufacturing site located
in Pfaffenhofen, Germany.
Legal disclaimer (Forward-looking statement)
This press release contains forward-looking statements and
information about future developments in the sector, and the legal
and business conditions of DAIICHI SANKYO, Co. Ltd, DAIICHI SANKYO,
Inc., and DAIICHI SANKYO EUROPE GmbH. Such forward-looking statements
are uncertain and are subject at all times to the risks of change,
particularly to the usual risks faced by a global pharmaceutical
company, including the impact of the prices for products and raw
materials, medication safety, changes in exchange rates, government
regulations, employee relations, taxes, political instability and
terrorism as well as the results of independent demands and
governmental inquiries that affect the affairs of the company. All
forward-looking statements contained in this release hold true as of
the date of publication. They do not represent any guarantee of
future performance. Actual events and developments could differ
materially from the forward-looking statements that are explicitly
expressed or implied in these statements. DAIICHI SANKYO, Co. Ltd,
DAIICHI SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH assume no
responsibility for the updating of such forward-looking statements
about future developments of the sector, legal and business
conditions and the company.
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
3. Fachinformation Sevikar(R) 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.
7. Mancia, G., et al. Reappraisal of European guidelines on
hypertension management: a European Society of Hypertension Task
Force document. J Hypertens;2009. 27: 2121-2158.
8. Gupta 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
9. Kearney PM, Whelton M, Reynolds K, et al. Worldwide prevalence
of hypertension: a systematic review. J Hypertens 2004;22:11-19
10. Bakris, et al. Preserving renal function in Adults with
Hypertension and Diabetes: A consensus approach. Am J Kidney Dis,
2000;36(3):646-661
Contact
    Public Relations
    Dr. Michaela Paudler-Debus
    Head of Product PR Europe
    Phone +49-89-78-08-685
     michaela.paudler-debus@daiichi-sankyo.eu
    Medical
    Joris Versteden
    Vice Director Medical and Scientific Affairs
    Phone +49-89-78-08-497
     joris.versteden@daiichi-sankyo.eu

Contact:

CONTACT: Contact: Public Relations, Dr. Michaela Paudler-Debus, Head
ofProduct PR Europe, Phone
+49-89-78-08-685,michaela.paudler-debus@daiichi-sankyo.eu. Medical,
Joris Versteden, ViceDirector Medical and Scientific Affairs, Phone
+49-89-78-08-497,joris.versteden@daiichi-sankyo.eu

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