Championing BiDil

When a compound fails to gain approval for a broad indication, companies often hold out hope that it will prove successful in a subgroup of the patient population and thus get to market for a more narrow indication. NitroMed Inc. is using that line of reasoning to push development of BiDil, a combination of hydralazine hydrochloride and isosorbide dinitrate to treat congestive heart failure (CHF).

BiDil was deemed non-approvable following a 1996 NDA submission by former licensee Medco Research Inc. (MRE, Research Triangle Park, N.C.). NitroMed said it will amend the NDA based on a published reanalysis of two pivotal trials and seek approval of BiDil to treat CHF in African-American patients...