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Inspra approved for improving survival of post-heart attack CHF patients

ROCKVILLE, MD., October 8, 2003 -- The FDA announced approval of a New Drug Application (NDA) for Inspra (eplerenone) tablets, for improving the survival of congestive heart failure patients (CHF) following an acute heart attack.

FDA reviewed Pfizer's application for the new use of Inspra on a priority basis, approving it within 6 months of receipt.

Originally approved in 2002 for treatment of hypertension, Inspra is the first member of the aldosterone receptor blocker class of drugs to receive approval for this CHF indication. Use of Inspra in the placebo-controlled clinical trial supporting its approval resulted in a significant (15%) reduction in the risk of death. This reduction and improved survival with Inspra occurred in patients who typically were receiving other appropriate therapy.

CHF is a common progressive disease that often occurs when the heart muscle is weakened after it has been injured from a heart attack or high blood pressure. It is estimated that nearly five million Americans suffer from CHF, and up to 700,000 new cases are diagnosed each year. According to the National Heart, Lung and Blood Institute, part of the National Institutes of Health, more than a million persons in the U.S. have a heart attack annually and about half (515,000) die. More than a third of heart attack survivors will develop heart failure and an increased risk of death. Half of the patients who develop heart failure will be dead within 5 years.

Patients who have had a heart attack are five times more likely to develop CHF than those who have not. Among patients over the age of 65, CHF is the number one reason for hospital admission and the leading cause of death. The costs to the health care system for treating CHF are estimated to be $20 billion to $40 billion annually.

Inspra, an aldosterone blocker, works by inhibiting the effects of aldosterone, a hormone that may contribute to the development and progression of hypertension and congestive heart failure, including damage to blood vessels, kidney and the heart.

FDA approval of Inspra for this indication is based on results of the EPHESUS (Epleronone Post-AMI Heart Failure Efficacy and Survival Study) trial which showed that Inspra significantly reduced deaths in congestive heart failure patients after a heart attack, above and beyond standard therapy, which included angiotensin-converting enzyme inhibitors (ACEs) and beta-blockers.

EPHESUS involved more than 6,600 patients who were hospitalized for heart attacks. There was a 15 percent reduction in the risk of death among patients who received Inspra compared to placebo, in addition to standard treatment. Further, Inspra-treated patients experienced a reduced risk of cardiovascular death and hospitalization. EPHESUS was published in the April 2003 issue of the New England Journal of Medicine.

Sources: FDA, Pfizer Inc.

Posted: October 2003