A US Food and Drug Administration advisory panel has recommended that AstraZeneca’s hypertension drug, Atacand (candesartan), be approved for concomitant use with the so-called ACE inhibitor class of drugs in the treatment of heart failure.
The panel voted unanimously in favour of the new indication, deciding that data from AstraZeneca’s CHARM-Added trial, which included some 2,548 patients, were sufficient to suggest that Atacand offers a distinct benefit on top of optimally dosed ACE inhibitors in reducing cardiovascular mortality and hospitalisations in heart failure. In the study, patients receiving Atacand and an ACE inhibitor showed a 15% lower risk for cardiovascular death or hospitalization, versus those receiving ACE inhibitors alone.
AstraZeneca filed for approval in this indication in June last year and is hoping to win the final green light by the end of April. Atacand was cleared earlier this week for the treatment of heart failure to reduce the risk of death from cardiovascular causes and reduce hospitalisation for heart failure based on the CHARM-Alternative trial in patients intolerant of ACE inhibitors [[24/02/05a]].