Answers
04/12/1994

<TITLE>FDA APPROVES TACROLIMUS FOR LIVER TRANSPLANT PATIENTS</TITLE>
<PRE>

T94-18                                         Susan Cruzan 
April 12, 1994                                 (301) 443-3285

      FDA APPROVES TACROLIMUS FOR LIVER TRANSPLANT PATIENTS

     FDA is receiving inquiries about its April 8, 1994, approval
of the drug tacrolimus (FK-506) for preventing graft rejection in
liver transplant patients.  The following may be used to answer
questions.
     Tacrolimus is the third immunosuppressant drug to receive FDA
approval for use in organ transplants.  Reports from early clinical
trials had suggested that it might be safer and better tolerated
than the two older transplant drugs--cyclosporine, used for heart,
liver and kidney transplants, and azathioprine, approved only for
kidney transplants.  
     On Nov. 22, 1993, an FDA advisory committee agreed unanimously
that later clinical trials have not shown tacrolimus to be safer or
more effective than cyclosporine-based treatments.  However, the
committee recommended approval of tacrolimus because it would
provide another alternative for preventing rejection of
transplanted livers.     
     These conclusions were based on two multicenter clinical
trials, each with more than 500 patients, that compared tacrolimus-
and cyclosporine-based treatments for liver transplants.  One study
                             -MORE-


                                       Page 2, T94-18, FK-506
was conducted in the United States and the other in Europe.  In
both trials, patient and graft survival rates were very similar for
the tacrolimus and cyclosporine groups.  
     Although adverse effects were somewhat different for the two
drugs, both were associated with neurological problems (headaches,
insomnia, tremors), metabolic disturbances (high blood sugar),
kidney disorders, high blood pressure, nausea and vomiting.  These
problems, which occur early in treatment, tend to subside with
time.
     In the tacrolimus/cyclosporine clinical trials, 75 to 88
percent of patients were still alive one year after surgery. 
Nationally, the one-year survival rate for all first-time liver
transplant patients is about 75 percent.  Approximately 3,000 liver
transplants are performed annually in the United States.
     Tacrolimus is manufactured by Fujisawa USA of Deerfield, Ill.,
and will be sold under the name Prograf.  
                              ####
</PRE>