Prograf Approved In Japan For Kidney Transplant

Fujisawa's immunosuppressant Prograf (tacrolimus) has been approved in Japan for a new indication, the suppression of rejection in kidney transplant patients. The additional indication was granted on April 16 by the Ministry of Health and Welfare.

Prograf, which acts in a similar way to ciclosporin A, was first launched in Japan in June 1993 for the suppression of rejection in liver transplantation. Just over a year later, it gained a supplemental approval for the treatment of graft-versus-host disease in bone marrow transplant patients.

Prograf was designated an orphan drug in both these indications, as the target patient population was so small. With this latest approval, the number of patients eligible to receive the drug goes up significantly, as kidney transplants are by far the most common transplantation procedure. Prograf has already been approved and launched for kidney transplantation in the UK, Germany and Denmark.