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.

upside down house — No sponsor, no application, no problem. • Source: Shutterstock

The final word in the name of the Center for Drug Evaluation and Research is often eclipsed by CDER’s more reactive evaluation and approval functions, but the Cardiovascular and Renal Drugs Advisory Committee meeting on 16 December 2020 will showcase the efforts of the FDA’s Division of Cardiology and Nephrology review staff to weigh and apply contemporary medical findings to the off-patent mineralocorticoid antagonist spironolactone.

The committee will consider a new indication for spironolactone for treatment of heart failure with preserved ejection fraction (HFpEF), based...