Astellas' Advagraf approved in Europe

Japanese drug major Astellas says that the European Commission has approved its immunosuppressant Advagraf (prolonged-release, tacrolimus) for prophylaxis of transplant rejection in adult kidney or liver allograft recipients and for the treatment of allograft rejection resistant to treatment with other immunosuppressants in adult patients throughout the European Union.

Astellas noted that the agent combines the proven safety and efficacy of Prograf (tacrolimus), the leading immunosuppressive for the prevention of rejection in organ transplantation, in a convenient, once-daily dosing option. The EC approval is based on the results of Phase II trials in liver, kidney and heart transplant patients and a Phase III study. One-year results showed that for efficacy failure rate, both Advagraf and Prograf groups were non-inferior to ciclosporin and had significantly less treatment failure and crossover due to treatment failure.