AstraZeneca submits regulatory application in Europe for use of Atacand(R) in heart failure

Main Category: Hypertension
Article Date: 08 Apr 2004 - 0:00 PDT

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Results of landmark CHARM study programme form the basis of heart failure submission for leading hypertension therapy, Atacand.

Mölndal, Sweden, 7 April - AstraZeneca today announced the submission of a regulatory application in the European Union (EU), as part of the Mutual Recognition Variation Procedure to obtain a new indication for Atacand (candesartan cilexetil), its angiotensin II type 1 (AT1) receptor blocker, for use in the treatment of heart failure. The UK acts as the RMS (Reference Member State). Further filings in the US and other markets are expected in the near future.

This submission follows the positive results of the CHARM (Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity) Programme, first presented at the European Society of Cardiology (ESC) in August 2003. CHARM proved Atacand, as the first AT1-receptor blocker, to reduce both cardiovascular deaths as well as hospital admissions, across a broad spectrum of patients with chronic heart failure1.

Additional analyses of the CHARM data, presented at the ACC (American College of Cardiology Meeting, New Orleans, 7-10 March), added further evidence for the benefits of Atacand in CHF. One analysis2 found that New York Heart Association (NYHA) functional class improved in a broad spectrum of CHF patients treated with Atacand.

Commenting on the heart failure submission for Atacand, Gunnar Olsson, VP and Head of the Cardiovascular Therapy Area said: "Heart failure remains a very serious, costly condition and there is still a real need for additional, effective therapies. It is a major cause of death, hospital admissions and self-reported quality of life is impaired more by CHF than by any other common chronic medical disorder3,4." He continued: "AstraZeneca is delighted that CHARM has shown that Atacand can benefit a broad range of heart failure patients. This file submission is a step further towards Atacand becoming available to doctors as a new and effective treatment option, offering more benefits to patients both in terms of better outcomes, including improved symptom control, reduced mortality, better quality of life, and better tolerability."

Atacand is an angiotensin II type 1 (AT1) receptor blocker indicated for the treatment of high blood pressure. As proven and leading antihypertension therapy, Atacand was first licensed in 1997 and has been shown to lower blood pressure more effectively than losartan, the initially introduced AT1-receptor blocker 5,6,7,8. Recent clinical outcome studies with Atacand, SCOPE and CHARM, have demonstrated the clinical value of the medicine in hypertension and heart failure, strengthening the position of Atacand as the premier AT1-receptor blocker in its class.

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Anette Orheim - AstraZeneca
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