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FDA Approves Nulojix for Kidney Transplant Patients
Date:6/15/2011

SILVER SPRING, Md., June 15, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today approved Nulojix (belatacept) to prevent acute rejection in adult patients who have had a kidney transplant. The drug is approved for use with other immunosuppressants (medications that suppress the immune system) -- specifically basiliximab, mycophenolate mofetil, and corticosteroids.

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Nulojix is a type of drug called 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). By preventing rejection, Nulojix, given through 30 minute intravenous infusions, works with other immunosuppressants to keep the new kidney working.

"Nulojix is a new option for kidney transplant patients," said Edward Cox, M.D., M.P.H., director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "This new medication used in combination with other immunosuppressants helps control the immune system and prevents organ rejection in patients receiving kidney transplants."

Nulojix was evaluated in two open-label, randomized, multicenter, controlled Phase 3 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 for the prevention of acute organ rejection.

Nulojix carries a Boxed Warning for an increased risk of developing post-transplant lymphoproliferative disorder (PTLD), a type of cancer where white blood cells grow out of control after an organ transplant. The risk of PTLD is higher for transplant patients who have never been exposed
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SOURCE U.S. Food and Drug Administration
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