Astellas submits NDA for Advagraf for prophylaxis of Organ Rejection

Astellas Pharma US has submitted a New Drug Application (NDA) to the FDA seeking approval for Advagraf (tacrolimus extended release capsules) for the prophylaxis of Organ Rejection in adult kidney transplant recipients and adult male liver transplant recipients. The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended release) kidney transplant recipients and 689 (393 tacrolimus extended release) liver transplant recipients conducted in the US, Canada, Europe, Australia, Brazil, New Zealand, among other sites. Astellas also has more than five years of follow-up patient data from the treatment of transplant recipients with tacrolimus extended release capsules. Astellas was granted marketing approval for tacrolimus extended release capsules under the trade name Advagraf in Europe in 2007 and under the trade name Graceptor in Japan in 2008. In total, tacrolimus extended release capsules have been approved for use in 69 countries.