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An organ transplant drug for patients receiving a new kidney has been recommended for approval in the US, despite mixed results in comparison with older drugs.
Bristol-Myers Squibb Co’s drug belatacept received a 13-5 vote in favour by the Food and Drug Administration drug advisory panel.
But panellists pointed out higher severe kidney rejection rates compared with drugs from Novartis and Abbott Laboratories, even though studies revealed that belatacept patients were more likely to survive two years after a kidney transplant and showed improved kidney function and lower blood pressure, both key predictors of survival.
FDA is not required to follow the group’s advice, though it often does.
New York-based Bristol presented its drug as a first-of-a-kind alternative to decades-old transplant drugs that cause headaches, nausea and occasionally liver toxicity.
Along with acute organ rejection, patients taking belatacept were more likely to contract a rare neurological disease known as progressive multifocal leukoencephalopathy, which attacks the brain and central nervous system and is usually fatal.
Copyright Press Association 2010