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NitroMed BiDil Recommended For Heart Failure In Self-Identified African-Americans

This article was originally published in The Pink Sheet Daily

Executive Summary

Indication to treat heart failure in the general population is discussed, but rejected, by FDA’s Cardiovascular & Renal Drugs Advisory Committee. Despite mortality benefit seen in A-HeFT, some committee members call strength of evidence a “close call.”

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NitroMed's BiDil Approved For Heart Failure In Self-Identified Black Patients

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.

NitroMed's BiDil Approved For Heart Failure In Self-Identified Black Patients

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.

NitroMed BiDil Heart Failure Indication For African Americans To Be Reviewed By Cmte.

FDA's Cardiovascular & Renal Drugs Advisory Committee will meet June 16 to consider the resubmitted BiDil NDA. Drug could be first approval specifically for African Americans. Committee will also meet June 15 to discuss antihypertensive class labeling.

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