Tacrolimus, developed by Astellas, is a once daily formulation of calcineurin-inhibitor immunosuppressant tacrolimus.
Astellas global transplantation therapeutic area head Roy First said 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," First added.
"This submission is another example of Astellas’ longstanding commitment to the transplant community and the well-being of transplant recipients."
Astellas has submitted the NDA based on six randomized and comparative studies of 2,842 kidney transplant recipients and 689 liver transplant recipients conducted in the US, Canada, Europe, Australia, Brazil and New Zealand.
Tacrolimus, which was approved in 69 countries, is marketed under the trade name of Advagraf in Europe and Graceptor in Japan by Astellas.