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The Food and Drug Administration has said an organ transplant drug from Bristol-Myers Squibb improves kidney function, but also appears to carry 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.
Similar drugs have been used for decades, but most carry risks of liver toxicity and other adverse effects.
In documents posted online, the FDA said more patients taking Belatacept survived two years following a kidney transplant compared with patients taking older drugs. Belatacept patients also showed improved kidney function and lower blood pressure, both key predictors of survival.
However, FDA drug reviewers also noted higher rates of severe kidney rejection in certain patients, as well as instances of a rare neurological disease.
The disease, known as progressive multifocal leukoencephalopathy, attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination and memory loss.
The FDA will ask a panel of outside advisers to vote on the drug’s safety and effectiveness next week. The agency is not required to follow the group’s advice, though it often does.
Copyright Press Association 2010
Bristol-Myers Squibb
