FDA panel back Bristol-Myers transplant drug

Mon, 03/01/2010 - 11:17am
The Associated Press

Federal health advisers say an organ transplant drug from Bristol-Myers Squibb Co. should be approved for patients receiving a new kidney.

The Food and Drug Administration panel has voted 13-5 in favor of the company's drug belatacept to prevent organ rejection in patients implanted with a new kidney.

FDA is not required to follow the group's advice.

Bristol has presented its drug as a new alternative to decades-old transplant drugs that cause headaches, nausea and occasional liver toxicity.

Belatacept patients in a study showed improved kidney function and lower blood pressure, key indicators of survival.

However, FDA drug reviewers noted higher rates of severe kidney rejection in patients compared with older drugs.


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