Second European Launch For Prograf

Fujisawa Pharmaceuticals will launch its immunosuppresive agent Prograf (tacrolimus) in Germany on April 12. The indications for the drug in its second market in Europe (the first being the UK) are the prevention of organ rejection and the treatment of manifest steroid-resistant organ rejection under cyclosporin-based immunosuppression in liver transplantation and kidney transplantation (if no other treatment is indicated).

Results from Phase III studies of the immunosuppressant 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 a 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.

Favored Over Ciclosporin Data from Fujisawa's European Phase III studies included over 1,000 patients who were treated at 20 sites. Acute rejection rates over the first year favored tacrolimus (68%) over ciclosporin (76%), and a Kaplan-Meier estimate of refractory rejection at one-year was 3% for tacrolimus and 15% for the Sandoz agent.