BiDilTreatment for Congestive Heart Failure
FDA Accepts NitroMed's New Drug Application Resubmission for BiDil; Submission Granted a June 23, 2005 PDUFA Date
LEXINGTON, Mass., February 3, 2005 - NitroMed, Inc. (NASDAQ: NTMD) announced today that the U.S. Food and Drug Administration (FDA) has accepted the 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% 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, 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 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% improvement in survival, a 33% reduction in first hospitalization for heart failure and an improvement in quality of life after taking BiDil. Adverse events reported in the trial included symptoms of headache and dizziness, which were significantly more frequent in the group given BiDil, and exacerbations of congestive heart failure (both moderate and severe), which were significantly more frequent in the placebo group. These results, which occurred with BiDil 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 Prevalence in African Americans
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, BiDil 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. BiDil 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, BiDil, like other medicines taken for chronic heart disease, will be taken for the duration of the patient's life.
About NitroMed, Inc.
NitroMed is an emerging pharmaceutical company focused on the research, development and commercialization of proprietary pharmaceuticals based on the therapeutic benefits of the naturally occurring molecule nitric oxide. The Company uses its expertise in nitric oxide biology and chemistry in an effort to develop both new pharmaceuticals, as well as safer, more effective versions of existing drugs. Research and development efforts focus on major diseases that are characterized by a deficiency in nitric oxide, such as cardiovascular and inflammatory diseases. BiDil, the Company's lead product candidate, is an orally administered nitric oxide-enhancing medicine being developed for the treatment of heart failure in African Americans. Corporate collaborations are also an element of the Company's business strategy, and NitroMed has an agreement with Boston Scientific to jointly develop nitric oxide-enhanced cardiovascular stents.
Posted: February 2005
- BiDil NitroMed, Inc. - Treatment for Heart Failure in Black Patients - June 23, 2005
- FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure - June 16, 2005
- Organizations Unite to Support BiDil's Approval for Heart Failure, Rebuff Designation as 'Race-Only' Drug - June 15, 2005
- FDA Schedules Advisory Committee Review of BiDil - April 29, 2005
- NitroMed Submits BiDil New Drug Application Amendment; Company Prepares for Commercialization of First Heart Failure Treatment for African Americans - December 23, 2004