From rxpgnews.com
Fixed Combination Isosorbide Dinitrate and Hydralazine Show Significant Survival Benefit in Heart Failure Patients
By Akanksha, Pharmacology Correspondent
Feb 5, 2005, 11:51
NitroMed, Inc.announced today that the U.S. Food and Drug Administration (FDA)has accepted the resubmission of the New Drug Application(NDA)for BiDil(R)(a fixed combination of isosorbide dinitrate and hydralazine)as a complete,Class 2 resubmission.
This fixed combination of isosorbide dinitrate and hydralazine,is the first heart failure treatment tested in an all African American patient population and recently demonstrated a 43% 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 this fixed combination of isosorbide dinitrate and hydralazine, to a community disproportionately burdened by heart failure," said Manuel Worcel,M.D.,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."
The African American Heart Failure Trial (A-HeFT), a phase III study testing this fixed combination of isosorbide dinitrate and hydralazine, 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 this fixed combination of isosorbide dinitrate and hydralazine.
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 this fixed combination of isosorbide dinitrate and hydralazine.
Adverse events reported in the trial included symptoms of headache and dizziness, which were significantly more frequent in the group given this fixed combination of isosorbide dinitrate and hydralazine, and exacerbations of congestive heart failure (both moderate and severe), which were significantly more frequent in the placebo group. These results, which occurred with this fixed combination of isosorbide dinitrate and hydralazine added to standard heart failure therapy, were presented at the American Heart Association's Scientific Sessions in November 2004 and were published in the New England Journal of Medicine.
Heart failure, or end-stage cardiovascular disease, affects approximately five million Americans. There is no cure for this disease, and more than 50 percent of patients die within five years of diagnosis. The African American community is affected at a greater frequency by heart failure than the corresponding Caucasian population. African Americans between the ages of 45 and 64 are 2.5 times more likely to die from heart failure than Caucasians in the same age range.
As the lead product in development for NitroMed, this fixed combination of isosorbide dinitrate and hydralazine,is an orally-administered nitric oxide-enhancing drug candidate that was investigated in A-HeFT for its potential, when administered together with standard heart failure therapies, to reduce mortality and hospitalization and improve the quality of life of African Americans diagnosed with heart failure.
It is a combination of two drugs, isosorbide dinitrate and hydralazine. Isosorbide dinitrate is a nitric oxide donor. Hydralazine is an antioxidant and vasodilator, which means that it protects nitric oxide formed by isosorbide dinitrate and dilates blood vessels. Neither drug separately is indicated for heart failure. Because heart failure is a chronic disease, if approved, this fixed combination of isosorbide dinitrate and hydralazine, like other medicines taken for chronic heart disease, will be taken for the duration of the patient's life.
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