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news.Astellas Pharma has received FDA approval for the use of Prograf (tacrolimus), in combination with mycophenolate mofetil (MMF), for the prevention of organ rejection in kidney transplant recipients. Prograf is a cornerstone therapy for preventing transplant rejection in liver, kidney and heart transplant recipients.
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The FDA’s approval was based on the review of two clinical studies involving approximately 2000 kidney transplant recipients.
A phase III, multi-center, open-label clinical trial was conducted where 424 kidney transplant recipients received Prograf 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 Prograf/MMF group was similar to the rate in the cyclosporine (CyA)/MMF group.
Goran B. Klintmalm, Chairman and Chief of the Baylor Regional Transplant Institute, said: “The FDA approval allows us to use the current standard of care as the control arm in future clinical studies to further advance the timely clinical development of new agents in transplantation.