European Mutual Recognition Procedure Approves Blopress(R) for Chronic Heart Failure Treatment

Main Category: Public Health
Article Date: 29 Nov 2004 - 11:00 PDT

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Osaka, Japan, Nov 29, 2004 - (JCN Newswire) - Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Mutual Recognition Variation Procedure (MRP) evaluating the use of Blopress(R) (candesartan cilexetil), a selective angiotensin receptor blocker (ARB) in the treatment of chronic heart failure (CHF) has been completed. Blopress(R), already a well established antihypertensive therapy, is now indicated for the treatment of patients with heart failure and impaired left ventricle systolic function. The UK was the MRP Reference Member State for marketing approval across a number of EU countries*.

This new approval identifies Blopress(R) as the first ARB with such a broad indication for use in the treatment of CHF. The new indication states that Blopress(R) can be included as an effective additional treatment in those patients who are already taking a comprehensive range of drugs, including ACEi's and beta blockers and also given as an alternative to an ACE inhibitor (ACEi) in those patients who have developed ACEi intolerance.

The approval of a CHF indication for candesartan is based on the positive results of the CHARM (Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity) clinical trial programme, first presented at the European Society of Cardiology (ESC) Congress in August 2003. The results from CHARM identified candesartan as the first ARB to reduce both deaths as well as heart failure hospital admissions, in chronic heart failure patients with impaired left ventricle systolic function, whether or not they are taking an ACE-inhibitor 1,2,3.

"Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products," said Dr. Kiyoshi Kitazawa, Ph.D., General Manager of Pharmaceutical Development Division of Takeda. "We believe this new approval will contribute to offer additional treatment options and to improve the quality of life of CHF patients."

Takeda submitted the European regulatory application for the new CHF indication in April this year. In August 2004, Takeda announced that the European Mutual Recognition Procedure for a 32 mg Blopress(R) tablet in hypertension had been completed, meaning that a wider range of doses of Blopress(R) are now available for the treatment of hypertension. 32 mg once daily is also the target dose for CHF as used in the CHARM Programme.

CHARM study was sponsored and conducted by AstraZeneca. Candesartan was discovered and originally synthesized by Takeda Pharmaceutical Company Limited, and it was jointly developed with AstraZeneca. Candesartan is marketed worldwide under the brand name of Blopress(R) by Takeda and Atacand(R) by AstraZeneca in more than 70 countries.

*France was not included in the Mutual Recognition Procedure for the CHF indication. **Blopress(R) is marketed in the UK as Amias(R) and France as Kenzen(R). ***The MRP on this occasion covers all EU countries apart from France. The reference member state during this procedure has been the UK. (EU countries excluding France and prior to 2004 expansion. Belgium, Denmark, Germany, Greece, Spain, Ireland, Italy, Luxembourg, Netherlands, Austria, Portugal, Finland, Sweden, United Kingdom)

References

1. Young JB, Dunlap ME, Pfeffer MA, Probsfield JL, Cohen-Solal A, Dietz R et al. for the CHARM Investigators and Committees. Mortality and Morbidity Reduction with Candesartan in Patients with Chronic Heart Failure and Left Ventricular Systolic Dysfunction: Results of the CHARM Low Left Ventricular Ejection Fraction Trials. Circulation 2004;110:2618-26.

2. McMurray JJV, Ostergren J, Swedberg K, Granger CB, Held P, Michelson EL et al. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial. Lancet 2003;362:767-71.

3. Granger CB, McMurray JJV, Yusuf S, Held P, Michelson EL, Olofsson B et al. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors: the CHARM-Alternative trial. Lancet 2003;362:772-6.

About Takeda Pharmaceutical Company, Ltd.

Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the industry's leaders worldwide, Takeda's management mission is "to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products." In addition, Takeda aims to be "a company that grows together with its stakeholders." Takeda is actively engaged in social contribution activities aiming to become a good corporate citizen in the world.

Contact:

TAKEDA PHARMACEUTICAL COMPANY LIMITED
Medical Information
Makoto Iwane
Strategic Development Dept.
Pharmaceutical Development Div.
Tel: +81-6-6204-5302
E-mail: Iwane_Makoto@takeda.co.jp

Corporate Information
Shouji Wakayama
Public Relations & Corporate Communications Dept.
Tel: +81-6-6204-2412
E-mailWakayama_Shouji@takeda.co.jp

View Takeda Pharmaceutical Company, Ltd. company profile here

Nov 29, 2004
Source: Takeda Pharmaceutical Company, Ltd.
Takeda Pharmaceutical Company, Ltd. (TSE: 4502) (NYSE: TDCHF)
From the Japan Corporate News Network
http://www.japancorp.net
Topic: Drug Approval

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