NitroMed drug cut deaths in blacks

	Tweet

NitroMed Inc.’s heart-failure drug for African-Americans reduced deaths and hospitalizations and its side effects were similar to a placebo’s, U.S. regulatory staff said on Wednesday.

The drug, BiDil (hydralazine HCL and isosorbide), should be indicated for use in black patients, the group that NitroMed studied, an FDA staff analysis said. BiDil has generated controversy as the first medicine targeted to one race of patients.

NitroMed’s study “has shown that BiDil reduced mortality and the risk of (heart failure) hospitalization in African American heart failure patients,” the review said, adding, “BiDil should be indicated in the same population in whom it was studied.”

The FDA staff review was released ahead of a Thursday advisory panel meeting, where outside experts will decide whether to recommend approval for BiDil.

Shares of Lexington, Massachusetts-based NitroMed rose 67 cents, or 3.6 percent, to $19.32 in morning trading on Nasdaq. 

RELATED STORIES:
Tamiflu best for bird flu, but avoid steroids   Anti-Depressant Drugs Can Double Risk of Gastrointestinal Bleeding   The first and only fusion inhibitor for the treatment of HIV   Drug firms offer saving card for U.S. uninsured   Roche seeking others to make Tamiflu bird flu drug   Cholesterol meds highlight conflict of interest debate in medicine   Elderly skip cholesterol and blood pressure drugs   Europe orders full safety probe of Cox-2 drugs   Few Americans Buy Meds Online   Celebrex prescriptions plunge after risk found - WSJ   New reference material can improve testing of multivitamin tablets   Efficacy of blood pressure drug questioned

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]