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Supplemental NDA Submitted for Candesartan Cilexetil for the Treatment of Chronic Heart Failure

WILMINGTON, Del., July 1 /PRNewswire-FirstCall/ -- AstraZeneca announced today that it has submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for a new indication for its angiotensin receptor blocker (ARB), ATACAND® (candesartan cilexetil), for the treatment of chronic heart failure (CHF). ATACAND is currently approved for the treatment of hypertension.

The sNDA submission is based primarily on results from the clinical trial program known as CHARM (Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity), the most comprehensive trial program completed to date with an ARB for heart failure. CHARM was an international, multicenter program involving 7,601 patients with classic symptoms of chronic heart failure. CHARM was comprised of three independent, parallel, double blind, placebo controlled studies of ATACAND: patients with left ventricular systolic dysfunction (LVEF less than or equal to 40%) in addition to standard therapy including an ACE inhibitor (CHARM - Added); patients with LVEF less than or equal to 40% who were intolerant of ACE inhibitors (CHARM - Alternative); and patients with preserved left ventricular systolic function (LVEF > 40%) (CHARM - Preserved).

CHARM demonstrated the effects of ATACAND on cardiovascular deaths and hospital admissions for heart failure when compared to placebo, across a broad spectrum of patients with symptomatic heart failure. The initial CHARM results were presented at the 2003 European Society of Cardiology Congress(1) and published in 4 articles in the September 6, 2003 issue of The Lancet.(2,3,4,5)

ATACAND and Hypertension

ATACAND is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. The usual recommended starting dose of ATACAND for the treatment of hypertension is 16 mg once daily as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. The three most common adverse events occurring with ATACAND more often than placebo in the treatment of hypertension were upper respiratory tract infection (URI) (6% vs. 4%), dizziness (4% vs. 3%), and back pain (3% vs. 2%).

IMPORTANT SAFETY INFORMATION

PREGNANCY WARNING: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, ATACAND should be discontinued as soon as possible. For full Prescribing Information for ATACAND, including boxed WARNING, call 1-800-236-9933 or visit http://www.atacand-us.com/.

About Chronic Heart Failure

Chronic heart failure (CHF) is a condition in which the heart is unable to pump blood adequately to the rest of the body. When the heart is not pumping, as it should, less oxygen and nutrients are carried through the body, and some of the wastes may not be removed from the body. This can result in fatigue, shortness of breath, and fluid buildup in the lungs, liver, or ankles. It is a serious, progressive, debilitating condition and frequently leads to a fatal outcome.

Common causes of heart failure include coronary artery disease, heart attacks (or myocardial infarction), high blood pressure (or hypertension), and heart disease of unknown origin (or cardiomyopathy).

The American Heart Association estimates that nearly 5 million Americans are currently living with heart failure, and more than half a million new cases are diagnosed each year.

REFERENCES (1) Granger C, et al. Candesartan in heart failure (CHARM Programme) [Hotline Session]. Presented at: European Society of Cardiology Congress: August 2003: Vienna, Austria. (2) Pfeffer MA, Swedberg K, Granger CB et al. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall Programme. Lancet 2003; 362: 759-66. (3) Granger CB, McMurray JJV, Yusuf S, et al. Effects of candesartan in patients with chronic heart failure and reduced left ventricular systolic function and intolerant to ACE inhibitors: the CHARM- Alternative Trial. Lancet 2003; 362: 772-76. (4) McMurray JJV, Ostergren J, Swedberg K, et al. Effects of candesartan in patients with chronic heart failure and reduced left ventricular systolic function treated with an ACE inhibitor: the CHARM-Added Trial. Lancet 2003 362: 767-71. (5) Yusuf S, Pfeffer MA, Swedberg K, et al. Effects of candesartan in patients with chronic heart failure and preserved left ventricular systolic function: the CHARM-Preserved Trail. Lancet 2003 362: 777-81.

Source: AstraZeneca

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