Prograf approved for combination therapy with mycophenolate mofetil (MMF) in kidney transplant recipients

The FDA has approved Prograf (tacrolimus, from Astellas) in conjunction with mycophenolate mofetil (MMF) for the prevention of organ rejection in kidney transplant recipients. This approval was based on results from two clinical studies. In a Phase 3, multi-center, open-label clinical trial, 424 kidney transplant patients received Prograf or cyclosporine in combination with MMF, basiliximab induction, and corticosteroids. The combined endpoint of biopsy proven acute rejection, graft failure, death, and/or lost to follow-up at 12 months in the Prograf/MMF group was similar to the rate in the cyclosporine/MMF group. In a second prospective, randomized, multi-center, open-label, parallel-group clinical trial, 1,589 kidney transplant recipients were randomized to receive standard dose cyclosporine, MMF, and corticosteroids; or daclizumab induction, MMF, and corticosteroids in combination with either low-dose cyclosporine, Prograf, or sirolimus. The primary endpoint of the study was renal function, measured by estimated glomerular filtration rate (GFR), at 12 months after transplantation. Secondary endpoints included acute rejection, graft survival, and overall mortality. Patients treated with Prograf exhibited higher estimated creatinine clearance rates and experienced fewer efficacy failures (defined as biopsy proven acute rejection, graft loss, death, and/or lost to follow-up) in comparison to each of the other three groups: Prograf/MMF (20.4%), cyclosporine/MMF (36.2% and 31.6%), and sirolimus/MMF (46.4%). Mortality at 12 months in patients receiving Prograf was similar to the other three groups: Prograf/MMF (2.7%), cyclosporine/MMF (3.3% and 1.8%), and sirolimus/MMF (3.0%).

Prograf is available in a capsule formulation as well as an injection for IV infusion. It is already indicated for the prophylaxis of organ rejection in patients receiving allogenic liver, kidney, or heart transplants.

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