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FDA Approves Tacrolimus Plus Mycophenolate Mofetil for Prevention of Kidney Rejection in Transplant Recipients NEW YORK -- May 28, 2009 -- The US Food and Drug Administration (FDA) has approved tacrolimus (Prograf) in conjunction with mycophenolate mofetil (MMF) for the prevention of organ rejection in kidney transplant recipients. The approval is based on the review of 2 studies involving approximately 2,000 kidney transplant recipients. The first study was a phase 3, multicentre, open-label trial included 424 kidney transplant recipients who received tacrolimus or cyclosporine in combination with MMF, basiliximab induction, and corticosteroids. The study reported that the rate for the combined endpoint of biopsy proven acute rejection, graft failure, death and/or lost to follow-up at 12 months in the tacrolimus /MMF group was similar to the rate in the cyclosporine/MMF group. There was, however, an imbalance in mortality at 12 months in those patients receiving tacrolimus /MMF (4.2%) compared with those receiving cyclosporine/MMF (2.4%), including cases attributed to overimmunosuppression. A second comparative clinical study was a prospective, randomised, open-label, multicentre study in 4 parallel groups of kidney transplant recipients. The study randomly assigned 1,589 kidney transplant recipients to receive standard dose cyclosporine, MMF, and corticosteroids; or daclizumab induction, MMF, and corticosteroids in combination with low-dose cyclosporine, tacrolimus or sirolimus. The primary endpoint of the study was renal function, measured by estimated glomerular filtration rates (GFR), at 12 months after transplantation. Acute rejection, graft survival, and overall mortality were also assessed as secondary endpoints. Mortality at 12 months in patients receiving tacrolimus/MMF (2.7%) was similar compared with patients receiving cyclosporine/MMF (3.3% and 1.8%) or sirolimus/MMF (3.0%). Patients in the tacrolimus group exhibited higher estimated creatinine clearance rates (eCLcr) using the Cockcroft-Gault formula and experienced fewer efficacy failures, defined as biopsy proven acute rejection (BPAR), graft loss, death and/or lost to follow-up in comparison to each of the other 3 groups: tacrolimus /MMF (20.4%), cyclosporine/MMF (36.2% and 31.6%) and sirolimus/MMF (46.4%). Median creatinine clearance rate at 12 months was higher in the tacrolimus group (66.2ml/min) than in the other 3 groups (range, 56.9-60.9ml/min). The BPAR was also lowest (15.0%) in the tacrolimus arm when compared with the standard-dose cyclosporine (29.0%), low-dose cyclosporine (26.6%) or sirolimus (38.1%) groups. Graft loss excluding death was also lowest in the low-dose tacrolimus group (3.0%), followed by the low-dose cyclosporine group (5.0%), the standard-dose cyclosporine group (7.2%), and the sirolimus group (7.5%). SOURCE: Astellas E-mail this page to a friend or colleague! To print, use this version