NitroMed Hopes To Reach 35% Tier II Formulary Coverage For BiDil By End Of March
This article was originally published in The Pink Sheet Daily
Tier II reimbursement is “critical” to success of the dual vasodilator for African-Americans with heart failure, company says.
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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.
Bayer’s kidney cancer drug brought in $25.2 mil. (€20 mil.) in the first quarter following its approval late last year.
The firm is conducting small studies of short duration after meeting with FDA regarding a May 2005 “approvable” letter.