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Cardiovascular and Renal Drugs Advisory Committee

December 16

The committee will discuss spironolactone for the proposed treatment of heart failure with preserved ejection fraction, a serious and often fatal condition for which no drug is approved to improve outcomes. The data supporting the new indication are post-hoc analyses of the National Heart, Lung, and Blood Institute sponsored Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist trial, which nominally failed to meet its primary endpoint. Spironolactone is currently marketed in the U.S. for the treatment of heart failure with reduced ejection fraction, hypertension, primary hyperaldosteronism, and for the management of edema. Docket: FDA-2020-N-1330

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Date:
December 16
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