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Astellas Receives FDA Approval for Use of Prograf(R) (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients
Date:5/28/2009

he New England Journal of Medicine.

In this second study, mortality at 12 months in patients receiving Prograf/MMF (2.7%) was similar compared to patients receiving cyclosporine/MMF (3.3% and 1.8%) or sirolimus/MMF (3.0%). Patients in the Prograf 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 three groups: Prograf/MMF (20.4%), CyA/MMF (36.2% and 31.6%) and Siro/MMF (46.4%).

Median creatinine clearance rate, a measure of kidney function (eCLcr) at 12 months was higher in the Prograf group (66.2ml/min) than in the other three groups (range, 56.9 to 60.9ml/min). The BPAR was also lowest (15.0%) in the Prograf arm when compared to the standard-dose CyA (29.0%), low-dose CyA (26.6%) or sirolimus (38.1%) groups. Graft loss excluding death was also lowest in the low-dose Prograf group (3.0%), followed by the low-dose CyA group (5.0%), the standard-dose CyA (7.2%) and the sirolimus group (7.5%).

"After more than 20 years of commitment to the fields of immunology and transplantation, Astellas remains dedicated to the advancement of the science of immunosuppression to enhance the care of transplant patients," said M. Roy First, M.D., Vice President, Therapeutic Area Head, Transplantation for Astellas. "The approval of Prograf + MMF for use in kidney transplant patients provides further evidence of Astellas' ongoing commitment to developing the field of immunology and transplantation."

About Prograf(R) (tacrolimus)

Prograf(R) (tacrolimus capsules and injection) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. It is recommended that Prograf be
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