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Date: Thursday, December 11, 1997 FOR IMMEDIATE RELEASE Contact: FOOD AND DRUG ADMINISTRATION Lenore Gelb: (301) 827-6242 Broadcast Media: (301) 827-3434 Consumer Hotline: (800)532-4440
FDA today approved the licensing of the first monoclonal antibody to help prevent acute kidney transplant rejection. The product, daclizumab, is approved to be used in conjunction with a standard course of immunosuppressive therapy.
In 1996, about 11,100 people received kidney transplants. Approximately 40% of the time, signs of organ rejection appear, requiring additional intervention, including, in a small percentage of these cases, the need for another transplant or kidney dialysis. Organ transplant patients must take immunosuppressive agents for the rest of their lives, and some of these agents have significant negative side-effects.
"This new biotech product gives transplant patients and their doctors a new important weapon to fight kidney rejection," said Lead Deputy Commissioner Michael A. Friedman, M.D. "Adding daclizumab to other standard immunosuppressive treatments can be very beneficial for patients, with no evidence of additional serious side-effects."
Daclizumab is a genetically engineered version of a mouse antibody that has been manufactured to have mostly human components to make it safer. Using the techniques of biotechnology, identical, cloned antibodies can be produced in large quantities in the laboratory. The product works by suppressing the action of specific immune cells, called T-cells, that have been activated by the body to attack the transplanted organ as foreign tissue. Other non-activated T-cells in the immune system are not affected by daclizumab. Because it targets specific cells in the immune system, it has minimal additional side-effects for patients who must still take immunosuppressive drugs.
In the main clinical study involving 260 patients, after six months, 35% of patients who did not receive daclizumab showed signs of kidney rejection compared to 22% of those treated with daclizumab. All the patients in this study received cyclosporine, corticosteroids and azathioprine, the standard triple-therapy immunosuppressive regimen for kidney transplant patients.
Patients taking immunosuppressive treatment following organ transplantation are at increased risk for developing infections and lymphomas, a type of cancer. However, patients treated with daclizumab did not have more infections or other immune disorders than those in the placebo group. Studies are continuing to assess the long-term effects of daclizumab on the immune system.
Daclizumab is the first monoclonal antibody approved to help prevent signs of kidney rejection. It is the second monoclonal antibody approved to improve the success of organ transplants. The first one, muromonab-CD3 (Orthoclone OKT3), marketed by Ortho Biotech Inc., Raritan, N.J., is approved to treat patients who suffer acute kidney transplant rejection, as well as heart and liver transplant patients who are resistant to the standard steroidal treatment. However, it is not approved to prevent organ rejection.
Daclizumab will be marketed under the trade name Zenapax by Roche Laboratories Inc., Nutley, N.J. FDA reviewed and approved the license application in six months.