ASTELLAS SUBMITS MARKETING APPLICATION FOR IMMUNOSUPPRESSANT

A A

Japan-based Astellas Pharma has submitted a marketing application for the immunosuppressant FK506 modified release formulation (tacrolimus) to the Pharmaceuticals and Medical Devices Agency with the proposed indication of "suppression of organ rejection in organ transplantation" and "suppression of graft rejection and GVHD in bone marrow transplantation."

Tacrolimus is an immunosuppressant marketed for organ transplantation under the brand name Prograf in more than 70 countries. The new formulation is expected to be at least as safe as the conventional formulation since peak blood concentrations can be controlled at lower or even levels, said the company.