FDA approves Astellas' ASTAGRAF XL for prophylaxis of organ rejection in kidney transplant patients

Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) has approved ASTAGRAF XL^TM (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.

"Each transplant recipient is different and requires a personalized treatment approach. The approval of ASTAGRAF XL marks an important milestone in post-transplant care as it provides physicians with a new treatment option for kidney transplant recipients," said Sef Kurstjens, M.D., PhD., chief medical officer, Astellas Pharma, Inc. "Astellas is pleased to continue our more than 20-year commitment to the field of transplant immunology."

ASTAGRAF XL is the first once-daily oral tacrolimus formulation available in the U.S. for kidney transplant recipients. ASTAGRAF XL offers a potentially promising treatment option for appropriate kidney transplant recipients as a core component of an immunosuppressive regimen for the prophylaxis of organ rejection.

The two primary, randomized, comparative phase 3 clinical studies to support FDA approval enrolled 1,093 patients (545 on tacrolimus extended-release) in the U.S., Europe, Canada, South America, Australia and South Africa. Astellas was granted marketing approval for tacrolimus extended-release capsules under the trade name Advagraf^® in Europe in 2007 and under the trade name Graceptor^® in Japan in 2008. In total, tacrolimus extended-release capsules have been approved for use in 73 countries.