FDA clears new kidney transplant drug

The FDA has approved belatacept (Nulojix) for use with other immunosuppressants to prevent organ rejection among kidney transplant recipients.

Belatacept is a selective T-cell costimulation blocker administered through 30-minute intravenous infusions. It is approved for use with basiliximab, mycophenolate mofetil, and corticosteroids.

Belatacept was evaluated in two open-label, randomized, phase 3 studies that enrolled more than 1,200 patients. The studies compared two dose regimens of belatacept with cyclosporine.

The drug carries a boxed warning for an increased risk of developing post-transplant lymphoproliferative disorder (PTLD). The risk of PTLD is higher for transplant recipients who have never been exposed to Epstein-Barr virus (EBV). Transplant recipients who have not been exposed to EBV have more difficulty mounting an effective immune response to the virus if they get infected following transplantation. The virus is present in about 80% of donated organs. Patients should be tested for EBV and should only receive belatacept if testing shows they already have been exposed to EBV.

Common adverse reactions from belatacept observed in the clinical trials included anemia, constipation, kidney or bladder infection, and edema.

This article first appeared in Renal & Urology News, a sister publication to Clinical Advisor.

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