BioCentury on BioBusiness,
Tools & Techniques
Monday, September 13, 1999
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.
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