Astellas Pharma US, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. has submitted a New Drug Application (NDA) to the US 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. 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 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 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. First added, “This submission is another example of Astellas’ longstanding commitment to the transplant community and the well-being of transplant recipients.”

Astellas is a recognized leader in transplantation and has been committed to the field of immunology. The company is also dedicated to supporting the advancement of care for patients, continues to build upon its legacy and leadership in transplantation by investing in ongoing clinical research and new product development.

Astellas Pharma US, Inc., is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.