Takeda Pharmaceutical Company Limited has announced that the US FDA has approved its angiotensin receptor blocker (ARB) candesartan cilexetil, which is sold as Atacand by AstraZeneca in the US, for the treatment of heart failure (New York Heart Association Class II-IV and ejection fraction less than or equal to 40 percent) to reduce the risk of death from cardiovascular causes and reduce hospitalizations from heart failure.
Candesartan is the first ARB in the US to receive an indication for reducing both cardiovascular mortality and hospitalizations for heart failure.
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 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 US 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.