Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for tacrolimus extended release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.
Developed by Astellas, tacrolimus extended release capsules are a once daily formulation of calcineurin-inhibitor immunosuppressant tacrolimus. 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 U.S., 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 resulting in more than 140,000 patient years of experience.
"There remains a large unmet treatment need for transplant recipients who have a difficult time controlling their immunosuppression drug levels with existing products. Astellas believes tacrolimus extended release capsules, given the efficacy, safety profile and unique dosing schedule, offer a potentially promising treatment option for recipients," said Roy First, MD, Astellas Global Therapeutic Area Head for Transplantation. "This submission is another example of Astellas' longstanding commitment to the transplant community and the well-being of transplant recipients."
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