Astellas submits FK506 MAA to PMDA

Japanese drug major Astellas has submitted a marketing authorization application for the modified-release formulation of its immunosuppressant FK506 (tacrolimus) to the domestic drug regulator, the Pharmaceuticals and Medical Devices Agency, proposing the drug as a treatment for the suppression of organ rejection in transplantation and suppression of graft rejection and graft-versus-host disease in bone marrow transplantation.

Tacrolimus is marketed as an immunosuppressant for organ transplantation under the brand name Prograf in more than 70 countries. FK506 is a once-daily oral formulation of the drug which is expected to boost patient compliance compared to twice-daily administration with the conventional formulation. The FK506 modified-release product is therefore expected to be appropriate for a long-term protective effect.

Astellas noted that it has already submitted a New Drug Application for FK506 in the USA and a Marketing Authorization Application in Europe.