BMS Receives FDA Approval for Kidney Transplant Drug

Bristol-Myers Squibb got the FDA nod for Nulojix, its new drug to prevent acute rejection in adult patients who have undergone a kidney transplant.

Bristol-Myers Squibb announced that it has received approval from the FDA for Nulojix (belatacept) to prevent acute organ rejection in adult patients who have undergone a kidney transplant.

Nulojix is a selective T-cell costimulation blocker. The drug helps to prevent organ rejection after a kidney transplant. Without immunosuppression, the body can reject a transplanted organ because the immune system recognizes the new organ as foreign (transplant rejection).

Nulojix was evaluated in two open-label, randomized, multicenter, controlled Phase III studies that enrolled more than 1,200 patients and compared two dose regimens of Nulojix with another immunosuppressant, cyclosporine. These trials demonstrated that the recommended Nulojix regimen is safe and effective f