FDA approves first ‘ethnic’ heart drug

pharmafile | June 29, 2005 | News story | Research and Development, Sales and Marketing  

The FDA has approved BiDil as a new treatment for heart failure in black patients, a group disproportionately affected by the condition.

Developed by US pharma company Nitromed, BiDil is indicated to improve survival, prolong time to hospitalisation for heart failure and improve patient-reported functional status, as an adjunct to current standard heart failure therapy in self-identified black patients.

The approval was based on the two-year, 1,050 patient African American Heart Failure Trial (A-HeFT) that saw self-identified black patients taking BiDil in addition to current standard heart failure therapies.

African Americans between the ages of 45 and 64 are two and a half times more likely to die from heart failure, or end-stage cardiovascular disease, than Caucasians in the same age range, according to the Centres for Disease Control and Prevention.

BiDil is a combination of two older drugs, neither approved for heart failure – the anti-hypertensive hydralazine and the anti-anginal isosorbide dinitrate.

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