Astellas Pharma US Inc. announced Friday that the U.S. Food and Drug Administration has approved Astagraf XL, a once-daily anti-rejection drug for patients receiving a kidney transplant.
The drug is used with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. "Each transplant recipient is different and requires a personalized treatment approach," said Sef Kurstjens, MD, PhD., chief medical officer at Astellas. The company says Astagraf is the first once-daily oral tacrolimus formulation available in the U.S. for kidney transplant recipients.
In two primary, randomized, comparative phase 3 clinical studies, Astellas 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.