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.
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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.
Tale Of Two Adcomms: US FDA Handling Of Entresto Data May Have Helped Avoid Aducanumab’s Fate
Review divisions strongly encouraged filing of both the Novartis and Biogen drugs despite trials that missed their primary endpoints; with the heart failure drug, the agency took a more even-handed approach to presenting the data and was commended for its willingness to look beyond the narrowly missed p-value, in contrast to the barrage of criticism it faced with the Alzheimer’s drug.
Novartis’ Entresto Gains US FDA Panel Nod For New Heart Failure Claim
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.