Bristol-Myers Squibb announced that the FDA has approved Nulojix (belatacept), a selective T-cell costimulation blocker, in combination with other immunosuppressants to prevent acute organ rejection in adult patients who have had a kidney transplant. This approval was based on data from two open-label, randomized, multicenter, controlled Phase 3 studies that enrolled 1,200 patients and showed two dosage regimens of Nulojix to be safe and effective compared with cyclosporine.
Nulojix carries a Boxed Warning for an increased risk of developing post-transplant lymphoproliferative disorder (PTLD), a type of cancer in which 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 to Epstein-Barr virus (EBV), the cause of mononucleosis. Transplant patients who have not been exposed to EBV have more difficulty mounting an effective immune response to the virus if they become infected after transplant; typically they are exposed to the virus at time of transplant, as it is carried in approximately 80% of donated organs. Patients should be tested for EBV and should receive Nulojix only if the test shows they have already been exposed to EBV.
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