Updated on 22 July 2013
Astellas gets FDA nod for kidney transplant drug
Singapore: Japan-based Astellas Pharma has received US FDA approval for Astagraf 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.
"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 Dr Sef Kurstjens, chief medical officer, Astellas Pharma, US. "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 US for kidney transplant recipients. It 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.