FDA approves Nulojix for kidney transplant patients

The U.S. Food and Drug Administration (FDA) on Wednesday approved Nulojix to prevent acute rejection in adult patients who have had a kidney transplant. The drug is approved for use with other immunosuppressants. 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, director of 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. According to the FDA, common adverse reactions observed in transplant patients in the trials included low red blood count, constipation, kidney or bladder infection, and swollen legs, ankles, or feet. More than 89,000 patients are waiting for a kidney transplant in the United States, according to the Organ Procurement and Transplantation Network, which is overseen by Department of Health and Human Service's Health Resources and Services Administration.