PARIS, June 20, 2011 /PRNewswire/ --
- European Commission approves NULOJIX(R) (belatacept), in combination with corticosteroids and a mycophenolic acid and an interleukin-2 receptor antagonist at induction, for prophylaxis of graft rejection in adult patients receiving a kidney transplant - First new mode of action for prevention of graft rejection in kidney transplantation in a decade - Similar rates of graft and patient survival with better preservation of renal function seen at one year and maintained through three years vs. cyclosporine - Overall safety profile of belatacept comparable to cyclosporine; higher rates of post-transplant lymphoma especially in EBV seronegative patients
Bristol-Myers Squibb today announced that the European Commission has granted Marketing Authorization for NULOJIX(R) (belatacept), a new biologic agent for the prophylaxis of graft rejection in adult patients receiving a kidney transplant.
Belatacept is the first molecule with a new mechanism of action approved in a decade in kidney transplantation. By acting selectively on the immune system to prevent graft rejection, belatacept helps safeguard renal function, which is increasingly recognized as a key predictor of long term outcomes in kidney transplant recipients, impacting both patient and graft survival.[1,2,3]
"One of the key challenges in kidney transplantation has been achieving improvements in renal function that are sustained in the long term," said Professor Josep Grinyó of the University Hospital of Bellvitge, Spain. "We observe progressive renal function decline in our patients, which may cause additional co-morbidities and result in graft failure. With belatacept's positive impact on renal function, this approval represents a promising new option for adult kidney transplant patients."
Approximately 18,000 kidney transplants were performed in the European Union in 2009. As of 31 December 2009, however, more than 50,000 people across the 27 countries were still in need of a kidney transplant. Preserving renal function after transplantation can help avoid a return to dialysis and the need for another transplant.
"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."
Belatacept, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for the prophylaxis of graft rejection in adults receiving a renal transplant. It is recommended to add an interleukin (IL)-2 receptor antagonist for induction therapy to this belatacept-based regimen. Belatacept is contraindicated in transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.
The Marketing Authorization for belatacept follows the positive opinion by the Committee for Human Medicinal Products, which considered that there is a favorable benefit to risk balance for belatacept on the basis of quality, safety and efficacy data submitted. The two pivotal Phase III clinical trials (BENEFIT and BENEFIT-EXT[7,8])have been extended to seven years in duration and will, upon completion, provide the largest set of controlled long term data of a transplant immunosuppressive regimen to date.
Following approval from the European Commission, belatacept is expected to become commercially available in the European Community in the coming months.