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The European Commission has authorised marketing of NULOJIX®(belatacept) with corticosteroids, a mycophenolic acid and an interleukin-2 receptor antagonist for prophylaxis of graft rejection in adults receiving a kidney transplant.
Belatacept is the first molecule with a new mode of action approved for prevention of graft rejection after kidney transplantation in a decade.
Rates of graft and patient survival achieved by patients receiving belatacept for one year were similar to those seen in patients given cyclosporine while renal function was better preserved with belatacept.
These stable graft and patient survival and enhanced renal function observations with belatacept were maintained after three years of treatment.
Overall, the safety profile of belatacept was similar to that seen with cyclosporine although rates of post-transplant lymphoma was increased – especially in patients seronegative for Epstein-Barr virus.
“As the first new biologic therapy approved for the prevention of graft rejection in kidney transplantation in a decade, Nulojix gives kidney transplant recipients a new innovative treatment option,” said Ron Cooper, President, Europe, Bristol-Myers Squibb. “What we see today with Nulojix is that it helps preserve kidney function after transplantation and we know that this is critical for patients to keep their graft healthier for longer.”