Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.AstraZeneca has received approval from the FDA for its Atacand tablets for the treatment of heart failure, making the product the first of its kind to receive an indication for reducing both cardiovascular mortality and hospitalizations for heart failure.
Subscribe to our email newsletter
Atacand (candesartan cilexetil) is an angiotensin receptor blocker (ARB), manufactured under license from Takeda, that is already on the market for the treatment of high blood pressure.
The approval was primarily based on results from a company-sponsored trial, CHARM-Alternative, which examined the effect of Atacand compared to placebo in over 2,000 heart failure patients who were intolerant to ACE inhibitors, but were receiving other standard heart failure therapy.
The trial demonstrated that in these chronic heart failure patients, the use of Atacand resulted in a 23% relative risk reduction in cardiovascular death or heart failure hospitalization. This finding was supported by a second study, CHARM-Added, in which subjects were mostly on submaximal doses of ACE inhibitors.
Together, in these studies, patients on Atacand had a 15% lower risk of cardiovascular mortality, as well as improvements in symptoms of heart failure.