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T03-68 |
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The Food and Drug Administration (FDA) today announced the approval of Inspra (eplerenone) tablets for improving the survival of congestive heart failure patients following an acute heart attack.
Inspra is the first member of the aldosterone receptor blocker class of drugs to receive approval for this indication. The use of Inspra in the placebo-controlled clinical trial supporting its approval resulted in a significant (15%) reduction in the risk of death. The reduction in the risk of death and improved survival with Inspra occurred in patients who were typically receiving other appropriate therapy.
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.
Pfizer Inc. is the sponsor of the approved New Drug Application (NDA) for
Inspra. FDA first approved Inspra in 2002 for the treatment of hypertension.
FDA reviewed the sponsor’s application for the new use of Inspra on a
priority basis, approving it within 6 months of receipt.
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