FDA Approves Candesartan Cilexetil for the Treatment of Heart Failure

(I-Newswire) March 1, 2005 - The US approval was primarily based on results from Candesartan in Heart Failure Assessment of Reduction in Mortality and morbidity Alternative Trial (CHARM-Alternative), which examined the effect of candesartan (n= 1,013) compared to placebo (n=1,015) in 2,028 heart failure patients who were intolerant to ACE inhibitors, but were receiving other standard heart failure therapy. The trial demonstrated that, in these CHF patients, the use of candesartan resulted in a 23 percent (p<0.001) relative risk reduction in cardiovascular death or heart failure hospitalisation (406 events in the placebo arm compared to 334 events in the patients receiving candesartan), with both components contributing to this effect.

The results of CHARM study were presented at the 25th European Society of Cardiology (ESC) annual meeting (August 2003), followed by presentation of its additional analysis at the 53rd American College of Cardiology (ACC) annual meeting (March 2004) and 26th ESC (August 2004).

The approval of the CHF indication in the U.S. in addition to the one granted in EU in November 2004 is expected to provide further treatment options and improvement of QOL for CHF patients.

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

About CHARM

The CHARM Programme, which recruited 7,601 patients was conducted in heart failure with an AT1-receptor blocker. Patients with classic symptomatic chronic heart failure ? depressed left ventricular (LV) systolic function (Left Ventricular Ejection Fraction (LVEF) < 40%), were randomized into one of two studies ? either an ACE-inhibitor intolerant population (CHARM-Alternative), or the population treated with ACE-inhibitors (CHARM-Added). In addition, patients with preserved LV systolic function (LVEF> 40%) were also randomized into a third study (CHARM-Preserved). All patients received either candesartan cilexetil or placebo.

About Takeda

Takeda is a global research-based pharmaceutical company, largest in Japan and one of the leaders in the world. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.
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