Astellas' FK506 gets positive opinion from CHMP

Japanese drug major Astellas Pharma says that that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending marketing approval of the once-daily FK506 modified-release formulation of its immunosuppressant tacrolimus for the prevention of rejection in organ transplantation.

The product is a once-daily formulation of Astellas' twice-daily drug Prograf (tacrolimus), a leading immunosuppressive agent marketed in over 70 countries around the world for prevention of organ rejection in kidney, liver or heart transplant recipients.

According to the firm, the availability of a once-daily formulation dosing regimen may have the potential to increase patient compliance, and hence long-term efficacy of immunosuppression, representing a step forward in the management of transplant patients. The CHMP based its opinion on its review of the data package for FK506, which characterized its efficacy and safety profile. The indication for FK506 is the prophylaxis of transplant rejection in adult kidney or liver allograft recipients.