The Food and Drug Administration has approved the licensing of the first monoclonal antibody to help prevent acute kidney transplant rejection.
The drug, daclizumab, will be marketed by Roche Laboratories under the trade name Zenapax.
Daclizumab is approved for use in conjunction with a standard course of immunosuppressive therapy. "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, MD. "Adding daclizumab to other standard immunosuppressive treatments can be very beneficial for patients, with no evidence of additional serious side effects."
In the main clinical study involving 260 patients, after six months, 35% of patients who did not receive daclizumab and 22% of those who did receive the drug showed signs of kidney rejection. All of the patients received cyclosporine, corticosteroids, and azathioprine, the standard triple-therapy immunosuppressive regimen for kidney transplant patients.
Although patients taking immunosuppressants following transplantation are at an increased risk for developing infections and lymphomas, patients treated with daclizumab did not have more infections or other immune disorders than patients who received a placebo. Studies are continuing to assess the long-term effects of daclizumab, the FDA said.
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. Muromonab-CD3, marketed as Orthoclone OKT3 by Ortho Biotech of Raritan, N.J., is approved for the treatment of patients with acute kidney transplant rejection and patients with heart and liver transplant who are resistant to the standard steroidal treatment.
Several news outlets reported a human-interest angle to the development of daclizumab. According to the Associated Press, one of the investigators who pushed the drug through the testing process has a three-year-old son who will someday need the drug. Jake Margolis was born in 1994 with a type of polycystic kidney disease. Although currently healthy, Jake is expected to eventually receive a kidney donated by his mother, pediatrician Susan Light. Light said that Jake will receive daclizumab with his treatment.
"How ironic that this happened in my life. At least now, I can feel I made a difference," Light told the Associated Press.
CNN Health: http://www.cnn.com/HEALTH/9712/11/transplant.rejection.ap/index.html
For Your Information:
US Food and Drug Administration announcement
http://www.fda.gov/bbs/topics/NEWS/NEW00606.htmlCNN Health article
http://www.cnn.com/HEALTH/9712/11/transplant.rejection.ap/index.html
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