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FDA has concerns with Bristol

2010-02-26 17:55:13 来源:


FDA has concerns with Bristol

FDA has concerns with Bristol transplant drug

WASHINGTON (AP) - The Food and Drug Administration says an organ transplant drug from Bristol-Myers Squibb improves kidney function, but the agency has concerns about potentially fatal side effects.

Bristol has asked the FDA to approve its drug Belatacept for patients undergoing a kidney transplant. The drug suppresses the body's immune system to avoid organ rejection.

In documents posted online, the FDA said more patients taking Belatacept survived two years following transplant compared with patients taking older drugs.

However, drug reviewers also noted higher rates of severe kidney rejection in certain patients, as well as neurological disease.

The FDA wants its outside advisers to vote on the drug's safety and effectiveness next week.

2010-02-25     15:26:45 GMT

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