AstraZeneca’s blood pressure drug Atacand (candesartan) has become the first drug in the angiotensin receptor blocker class to be approved in the USA for reducing both mortality and hospitalisations in patients with heart failure.
The ARB joins Novartis’ Diovan (valsartan), which is already approved in the US for use in heart failure in patients who cannot tolerate the older ACE inhibitor drugs. Diovan is the top-selling drug in the category, with 2004 sales of over $3 billion dollars [[21/01/05a]], while AstraZeneca booked $879 million dollars for Atacand in the same period [[28/01/05b]].
The approval follows clearance of the drug in the European Union for heart failure last year [[30/11/04d]]. Although smaller than the market for high blood pressure, heart failure still represents a sizeable opportunity for Atacand, particularly as it has a broader label than Diovan.
An estimated 20 million people worldwide have heart failure – compared to 690 million with hypertension – and it is likely to become even more common, partly due to an ageing population and improved survival after heart attack.
Atacand’s approval is based on the results of the 2,028-patient CHARM-Alternative study, which found that compared to placebo, candesartan reduced the rate of cardiovascular death or hospitalisation of heart failure by 30% [[01/09/03c]]. This study enrolled patients with heart failure who were not on ACE inhibitors, a standard treatment for heart failure, because they could not tolerate them.