FDA Approves Nulojix for Kidney Transplant Patients

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 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 get infected after transplant; typically they get exposed to the virus at time of transplant, as it is carried in around 80 percent of donated organs. Patients should be tested for EBV and should only receive Nulojix if the test shows they have already been exposed to EBV. Another Boxed Warning on the Nulojix label, as well as labels for other immunosuppressants, warns of an increased risk of serious infections and other cancers.

Common adverse reactions observed in transplant patients in the trials included low red blood count (anemia), constipation, kidney or bladder infection, and swollen legs, ankles, or feet. Any transplant patients, including those receiving Nulojix, should limit the amount of time spent in sunlight because of the risk of skin cancer and should not get live vaccines because of the risk of infection.

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 HHS' Health Resources and Services Administration.

Nulojix is marketed by Princeton, N.J.-based Bristol-Myers Squibb Company.

For More Information:

Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

National Institute of Diabetes and Digestive and Kidney Diseases

http://www2.niddk.nih.gov/

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Morgan Liscinsky, 301-796-0397, [email protected]
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SOURCE U.S. Food and Drug Administration