Astellas’ kidney transplant rejection treatment approved in US

Tokyo-based Astellas Pharma Inc. has announced that the US FDA has approved its drug, Astagraf XL, which is the first once-daily oral tacrolimus formulation available in the United States for kidney transplant recipients.

Astagraf XL (tacrolimus extended-release capsules) has been approved 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. Astellas is pleased to continue our more than 20-year commitment to the field of transplant immunology."

Sef Kurstjens, M.D., PhD., chief medical officer, Astellas Pharma, Inc.

The FDA's approval was based on two primary phase 3 clinical trials, where 1093 patients from the US, Europe, Canada, South America, Australia and South Africa evaluated Astagraf XL.

Astellas' drug has already been approved in Europe, under the trade name of Advagraf, in 2007 and as Graceptor in Japan in 2008. In total, tacrolimus extended-release capsules have been approved for use in 73 countries.