FDA backs Astellas' Astragraf XL for kidney transplant rejection prophylaxis

The US Food and Drug Administration has approved Japanese drug major Astellas Pharma’s (TYO: 4503) Astragraf XL (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.

The drug is a once-daily, modified-release version of the firm's Prograf (tacrolimus), which lost its US patent protection in April 2008. The drug had annual US sales of nearly $1 billion at that time.

"Each transplant recipient is different and requires a personalized treatment approach. The approval of Astragraf 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, chief medical officer, Astellas’ US subsidiary.