Under the Prescription Drug User Fee Act (PDUFA), the FDA review of the resubmission for BiDil (a fixed combination of isosorbide dinitrate and hydralazine) is expected to be completed on or before June 23, 2005.
A phase III study, named A-HeFT, was co-sponsored by NitroMed and the Association of Black Cardiologists (ABC), and was the first trial ever conducted in an all African American heart failure patient population. In July 2004, the trial was halted early due to the significant survival benefit seen in patients on BiDil.
A-HeFT results demonstrated that African American patients with heart failure experienced a 43% improvement in survival, a 33% reduction in first hospitalization for heart failure and an improvement in quality of life after taking BiDil.
However, although exacerbations of congestive heart failure were less frequent in the BiDil group compared to the placebo group, symptoms of headache and dizziness were significantly more frequent in the group given BiDil.
“This is an important step in NitroMed’s regulatory process for achieving our goal of bringing BiDil to a community disproportionately burdened by heart failure,” said Dr Manuel Worcel, chief medical officer for NitroMed. “While acceptance of the BiDil NDA resubmission does not ensure FDA approval, we believe that our clinical data demonstrate a significant benefit for African American heart failure patients.”