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Pharmaceutical industry

FDA Nears Approval of BiDil, First Drug Tied to Race

Strategic Insights

— 1 min read

The Food and Drug Administration is considering the approval of BiDil, a heart failure medication developed by NitroMed, which could become the first drug in the United States to be approved specifically for black people. According to a study, BiDil showed a significant benefit in reducing mortality rates among black patients with heart failure. The drug combines two generic medications that have been found to be effective in treating blacks, but not in the general population. NitroMed is seeking approval for BiDil as a treatment for heart failure, and if approved, it would mark a significant step towards personalized medicine.

Key Takeaways:

  • BiDil, a heart failure medication, has shown a significant benefit in reducing mortality rates among black patients with heart failure, according to a study.
  • The drug combines two generic medications that have been found to be effective in treating blacks, but not in the general population.
  • NitroMed is seeking approval for BiDil as a treatment for heart failure, which would be the first time a drug is approved specifically for a specific race.
  • The FDA has until June 23 to decide whether to approve BiDil.
  • The approval of BiDil could potentially pave the way for more personalized medicines that take into account genetic profiles.
  • NitroMed is a biopharmaceutical company based in Lexington, Massachusetts, that is developing BiDil.
  • The drug will be reviewed by a committee of FDA advisers meeting in Gaithersburg, Maryland.

Statistics:

  • 76 cents: The amount by which shares of NitroMed rose on the news of the potential approval of BiDil.
  • $19.41: The new stock price of NitroMed after the shares rose 76 cents.
  • June 23: The deadline by which the FDA must decide whether to approve BiDil as a treatment for heart failure.

Sources:

  • The New York Times, "F.D.A. Approves First Drug Based on Race"
  • Food and Drug Administration, "BiDil Review"
  • NitroMed, "About BiDil"
  • Associated Press, "FDA to Review Drug for Racially Specific Use"

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