NEWS
11/20/1995

<TITLE> FDA GRANTS ACCELERATED APPROVAL FOR 3TC WITH AZT TO TREAT
AIDS </TITLE>
<PRE>

P95-8                              Food and Drug Administration
FOR IMMEDIATE RELEASE              Arthur Whitmore (301)443-3285
Nov. 20, 1995                                         


FDA GRANTS ACCELERATED APPROVAL FOR 3TC WITH AZT TO TREAT AIDS

     The Food and Drug Administration today announced its
accelerated approval for the drug lamivudine, or 3TC, for use in
combination with AZT (zidovudine) in treating AIDS and HIV
infection.  
     AZT and 3TC are members of the nucleoside analogue class of
drug compounds, and both interfere with the replication of HIV, the
virus that causes AIDS.           
     Food and Drug Commissioner David A. Kessler, M.D., said the
3TC/AZT approval is the latest example of the agency's accelerated
review of drugs for HIV infection.  All currently marketed drugs
for treating HIV underwent such fast-track review and approval. 
The 3TC review was accomplished in four-and-a-half months.  
      "Of the five drugs now approved for the treatment of AIDS,
three were first approved for use in the United States," Kessler
said.  "We remain committed to accelerated approval as seen by the
review of 3TC.  At the same time, we have much to learn about the 
                             -more-

ATTENTION TV BROADCASTERS: Please use open caption for the hearing
impaired.
        FDA ON THE INTERNET: http://www.fda.gov/                                              Page 2, P95-8, 3TC
most effective combination therapies and we are equally committed
to getting the answers through the required post-marketing
studies."
     Accelerated approval is a regulatory mechanism which allows
FDA to grant early marketing status for a product based on
laboratory markers such as CD4 cell counts (a reflection of immune
system strength) rather than on clinical endpoints such as delay in
death or reduction in opportunistic infections.  Clinical benefit
must eventually be demonstrated for products receiving accelerated
approval.  Trials designed to demonstrate the clinical benefit of
the 3TC/AZT treatment regimen are currently ongoing.  
     The 3TC/AZT approval was based on data from four clinical
trials enrolling approximately 1,000 HIV-infected adults who
received either the combined 3TC/AZT therapy, 3TC as a single
therapy, AZT as a single therapy, or AZT and ddC (Roche Co.'s anti-
AIDS nucleoside analogue, which received accelerated approval in
1992). 
     The trials showed that patients treated with the 3TC/AZT
combination sustained higher increases of CD4 cells than patients
on the other three regimens.  On average, CD4 cell counts in
patients on the 3TC/AZT combination increased by 30 to 50 cells
above the levels at the start of the 24-week trials.  
      Adverse events were similar to those associated with other
nucleoside analogue drugs: nausea, diarrhea, anemia, low white 
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                                             Page 3, P95-8, 3TC
blood cells, pancreatitis (especially in children who had received 
prior nucleoside analogue therapy) and neuropathy.  Some of the
more severe adverse reactions required withdrawal from therapy.   
      3TC has been studied in humans since April 1991.  Since 
October 1993, the drug has been available to patients outside of 
controlled clinical trials under an open-label protocol.  More than
35,000 patients have received the drug under this expanded program,
which allows access to promising drugs for serious diseases prior
to marketing approval.
     3TC and AZT are manufactured by Glaxo-Wellcome Inc. of
Research Triangle Park, N.C.  The registered trade name for 3TC is
Epivir; for AZT, Retrovir.    
     Information on ongoing clinical trials on drugs for HIV 
infection may be obtained from the Public Health Service's AIDS 
Clinical Trial Information Service (ACTIS) at 1-800-TRIALS-A.
                             ####  
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