Astellas Pharma announced it has received FDA approval for Astragraf XL™ (tacrolimus extended-release capsules) for the prophylaxis of kidney rejection in patients receiving a transplant with mycophenolate mofetil and corticosteroids, with or without basiliximab induction.
The firm said its Astragraf XL is the first once-daily oral tacrolimus formulation available to kidney transplant recipients in the U.S. As part of an immunosuppressive regimen for the prophylaxis of organ rejection, “Astragraf XL offers a potentially promising treatment option for appropriate kidney transplant recipients,” Astellas said.
FDA’s approval stemmed from a review of results of two primary, randomized, comparative Phase III studied involving more than 1,000 patients in the U.S., Europe, Canada, South America, Australia, and South Africa. Astellas added that its drug earned marketing approval under the name Advagraf® in Europe in 2007, and a year later in Japan, under the name Graceptor®.
"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 Pharma CMO Sef Kurstjens, M.D., PhD., said in a statement.