HHS NEWS

P97-42                           FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE            Lenore Gelb:      (301) 827-6242
Dec 11, 1997                     
                                 Consumer Hotline: (800)532-4440         

    NEW BIOTECHNOLOGY PRODUCT APPROVED TO HELP PREVENT 
          REJECTION OF KIDNEY TRANSPLANTS


     FDA has 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. 

                         ####