US "approvable" letter for Astellas' FK506

Japanese drug major Astellas says that the US Food and Drug Administration has issued an "approvable" letter for once-daily FK506, a modified-release formulation of its immunosuppressant tacrolimus, for the prevention of rejection in patients receiving allogeneic kidney transplants. The firm says it is considering its future strategy on the drug and will work with the FDA to understand the issues raised.

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 the 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. Last year, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending marketing approval of the agent (Marketletter March 5, 2007). The opinion was based on a review of the data package for FK506, which characterized its efficacy and safety profile.