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| 29 November 2004 | 2004-11-29T00:00:00.0000000-00:00 |
| EUROPEAN MUTUAL RECOGNITION PROCEDURE APPROVES ASTRAZENECA’S ATACAND® FOR THE TREATMENT OF CHRONIC HEART FAILURE
AstraZeneca today announced that the European Mutual Recognition Variation Procedure (MRP) evaluating the use of Atacand® (candesartan cilexetil), a selective angiotensin receptor blocker (ARB) in the treatment of chronic heart failure (CHF) has been completed. Atacand, 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 differentiates Atacand as the first ARB with such a broad indication for use in the treatment of CHF. The new indication states that Atacand 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 Atacand 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 Atacand 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.
Gunnar Olsson, VP and Head of the Cardiovascular Therapy Area for AstraZeneca, said: "We are delighted that Atacand can now be used to treat the large population of patients with CHF, and not only hypertensives, since hypertension is a major risk factor for CHF. The results of CHARM proved that Atacand offers benefits in these patients not seen with other drugs in the ARB class. It is the only ARB shown to be well tolerated and effective both when used in ACEi intolerant patients and with any other heart failure therapy.”
AstraZeneca submitted the European regulatory application for the new CHF indication in April this year. Last August (2004), AstraZeneca announced that the European Mutual Recognition Procedure for a 32 mg Atacand tablet in hypertension had been completed, meaning that a wider range of doses of Atacand 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.
In July AstraZeneca submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for a new indication for Atacand for the treatment of chronic heart failure (CHF). The US FDA approval process is ongoing.
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Notes to editors
Atacand® is marketed in the UK as Amias® and Italy as Ratacand®
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)
AstraZeneca is a major international healthcare business engaged in the research, developmentmanufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index. AstraZeneca has more than 40 years’ experience in cardiovascular medicine and aims to increase lifespan and improve quality of life by reducing the risk, prevalence and impact of cardiovascular disease.
AstraZeneca has a comprehensive cardiovascular portfolio including CRESTOR™, Atacand®, ZESTRIL™, TENORMIN™, SELOKEN® ZOK /TOPROL-XL™ and Plendil™. This heritage is complemented by an innovative pipeline including the first oral direct thrombin inhibitor, Exanta™, and a novel treatment for type 2 diabetes / metabolic syndrome, GALIDA™. Candesartan Cilexetil is marketed by AstraZeneca under trademark Atacand®. Atacand® is manufactured under agreement from Takeda Pharmaceutical Company Limited.
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