Spironolactone TOPCAT Regional Analysis Falls Short At US FDA AdComm, But Hospitalizations Drive Vote
A new indication for the generic diuretic in heart failure with preserved ejection fraction gets an 8-4 vote, with one abstention, despite troubles an analysis that tries to revive the TOPCAT trial with an analysis excluding Eastern European sites – or about half the participants.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
But advisory committee members debate how to define the target population for a new indication, shying away from use of ‘preserved’ to characterize heart failure patients with ejection fraction levels below normal but greater than the definition of ‘reduced’ EF.
Spironolactone Starts Out On ‘Unusual But Not Unprecedented’ Regulatory Path, Thanks To US FDA Reviewers
Despite the lack of a sponsor or an application, FDA’s cardio-renal advisory committee will consider a possible new indication for the generically available drug in heart failure with preserved ejection fraction (HFpEF), driven by agency analysis of the NIH-sponsored TOPCAT trial.