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Astellas applies for FDA approval of organ transplant drug

Drug maker submits application for tacrolimus in kidney, liver transplant recipients

NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.

Astellas Pharma US said it applied with the FDA for approval of tacrolimus extended-release capsules to prevent rejection of transplanted kidneys in adults and transplanted livers in men. The drug was approved in Europe in 2007 under the name Advagraf and under the name Graceptor in Japan in 2008; the drug has been approved in 69 countries so far.

"There remains a large, unmet treatment need for transplant recipients who have a difficult time controlling their immunosuppression drug levels with existing products," Astellas global therapeutic area head for transplantation Roy First said. "Astellas believes tacrolimus extended-release capsules, given the efficacy, safety profile and unique dosing schedule, offer a potentially promising treatment option for recipients."


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