Regulators Raise Questions About Transplant Drug
WASHINGTON (AP) - The Food and Drug Administration said an organ transplant drug from Bristol-Myers Squibb Co. 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.
The panel will also assess Bristol-Myers' risk management plan for Belatecept. In its own briefing documents posted online, the New York company said it would educate doctors and patients on the drug's side effects.
Leerink Swann analyst Seamus Fernandez said recently the FDA meeting is "not a slam dunk," for Bristol-Myers, given its drug's risks.
While kidney specialists have praised the drug's ability to extend life expectancy, "they do not expect swift uptake because of the significantly higher rate of acute rejection seen with Belatacept," Fernandez stated in a recent investment note.
Assuming the drug is approved, he forecast sales of $50 million in 2010 and $650 million by 2016.
Date: February 27, 2010
Source: Associated Press