NitroMed's BiDil Approved For Heart Failure In Self-Identified Black Patients
This article was originally published in The Pink Sheet Daily
Executive Summary
The hydralazine/isosorbide dinitrate combination is the first approval for a race-based indication. In its recent review of BiDil, an FDA advisory committee suggested race was serving as a surrogate for genomic markers. FDA suggests further study could expand BiDil's approval beyond self-identified black patients.