Review of eplerenone gets underway in USA
The US Food and Drug Administration has accepted for review Pharmacia'sNew Drug Application for eplerenone, a selective aldosterone blocker, in the treatment of hypertension. The once-daily, orally-active drug is at the most advanced stage of any SAB in development, and the company believes that this compound's safety and tolerability will make it a useful addition to multidrug regimens in hypertension.
However, recent insights into the role of aldosterone in the development and progression of heart failure have suggested that SABs may offer a real benefit in this setting, and eplerenone is already in a Phase III trial (EPHESUS) in this indication, for which it could be filed in 2003. Pharmacia has predicted peak sales in the region of $1 billion if both these indications are approved.
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