The US FDA has accepted NitroMed's resubmission of the New Drug Application (NDA) for BiDil (a fixed combination of isosorbide dinitrate and hydralazine) as a complete, Class 2 resubmission. BiDil is the first heart failure treatment tested in an all African American patient population and recently demonstrated a 43 per cent survival benefit for African Americans in a phase III study.
Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period, beginning on the date that the resubmission was received. The PDUFA date for the BiDil NDA is June 23, 2005.
"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 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," he added.
The African American Heart Failure Trial (A-HeFT), a phase III study testing BiDil, was co-sponsored by NitroMed and the Association of Black Cardiologists (ABC). A-HeFT, the first trial ever conducted in an all African American heart failure patient population, enrolled 1,050 patients in a double-blind, placebo-controlled study at 169 clinical research sites. In July 2004, A-HeFT 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 per cent improvement in survival, a 33 per cent reduction in first hospitalization for heart failure and an improvement in quality of life after taking BiDil.
BiDil, the product in development for NitroMed, is an orally-administered nitric oxide-enhancing drug candidate. BiDil is a combination of two drugs, isosorbide dinitrate and hydralazine.