FDA PANEL BACKS FUJISAWA'S PROGRAF

Fujisawa's immunosuppressant compound Prograf (tacrolimus; formerly FK-506), is effective and safe for the prophylaxis of organ rejection in adult patients receiving allogeneic liver transplants, according to an advisory committee reporting to the US Food and Drug Administration.

Results from Phase III studies of the immunosuppressant were presented to the committee by Fujisawa USA. The results indicate that tacrolimus has comparable efficacy to Sandoz' Sandimmun (ciclosporin), a related drug which has become a benchmark agent in preventing transplant rejection.

The one-year patient survival rate for liver allograft recipients was 88% in the Phase III US trial (involving 555 patients at 12 centers), similar to the survival rate seen with ciclosporin. Graft survival rates were also similar, at 82% for the tacrolimus group and 79% for the ciclosporin group, according to Fujisawa USA director of R&D, William Fitzsimmons.