AstraZeneca announced that the European Mutual Recognition Variation Procedure (MRP) evaluating the use of Atacand (candesartan cilexetil), a selective angiotensin receptor blocker (ARB) in the treatment of chronic heart failure (CHF) has been completed. Atacand, already a well-established antihypertensive therapy, is now indicated for the treatment of patients with heart failure and impaired left ventricle systolic function.

This new approval differentiates Atacand as the first ARB with such a broad indication for use in the treatment of CHF. The new indication states that Atacand can be included as an effective additional treatment in those patients who are already taking a comprehensive range of drugs, including ACEi's and beta blockers and also given as an alternative to an ACE inhibitor (ACEi) in those patients who have developed ACEi intolerance.

The approval of a CHF indication for Atacand is based on the positive results of the CHARM (Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity) clinical trial programme, first presented at the European Society of Cardiology (ESC) Congress in August 2003. The results from CHARM identified Atacand as the first ARB to reduce both deaths as well as heart failure hospital admissions, in chronic heart failure patients with impaired left ventricle systolic function, whether or not they are taking an ACE-inhibitor, according to a company release.

Gunnar Olsson, VP and Head of the Cardiovascular Therapy Area for AstraZeneca, said: "We are delighted that Atacand can now be used to treat the large population of patients with CHF, and not only hypertensives, since hypertension is a major risk factor for CHF. The results of CHARM proved that Atacand offers benefits in these patients not seen with other drugs in the ARB class. It is the only ARB shown to be well tolerated and effective both when used in ACEi intolerant patients and with any other heart failure therapy."

AstraZeneca submitted the European regulatory application for the new CHF indication in April this year. Last August (2004), AstraZeneca announced that the European Mutual Recognition Procedure for a 32 mg Atacand tablet in hypertension had been completed, meaning that a wider range of doses of Atacand are now available for the treatment of hypertension. 32 mg once daily is also the target dose for CHF as used in the CHARM Programme, the release says.

In July, AstraZeneca submitted a supplemental New Drug Application (sNDA) with the US FDA seeking approval for a new indication for Atacand for the treatment of chronic heart failure (CHF). The US FDA approval process is ongoing.