News
06/22/1992

<TITLE>AIDS Drug Zalcitabine (ddC)</TITLE>
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P92-19                                         Food and Drug Administration
FOR IMMEDIATE RELEASE                          Faye Peterson - (301) 443-3285

    HHS Secretary Louis W. Sullivan, M.D., today announced that the Food and  
Drug Administration has approved the AIDS drug zalcitabine, commonly known    
as ddC.  It is the third drug licensed specifically for use in treating the   
human immunodeficiency virus, the cause of AIDS.
    Zalcitabine was approved for use in combination with the first approved   
AIDS drug, zidovudine -- or AZT -- as a treatment option for adult patients   
with advanced HIV infection who show signs of clinical or immunological       
deterioration.
    "This drug approval represents another step forward for patients with     
AIDS," Dr. Sullivan said.  "Zalcitabine has been rapidly developed, tested    
and reviewed through the cooperative efforts of scientists in the National    
Institutes of Health and FDA, academia and the pharmaceutical industry.
    Early clinical trial data have shown that increases in CD4 cells (immune  
cells) were somewhat greater and more sustained in patients treated with the  
combination of zalcitabine and zidovudine than in those who received          
zidovudine alone as initial therapy.  An increase in CD4 cells is believed    
to indicate that the body's disease-fighting capability has been at least     
transiently enhanced.
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                                            Page 2, P92-19, ddC
    At present, however, there are no study results demonstrating enhanced    
survival, lowered incidence of opportunistic infections or decreased          
progression of HIV infection for patients treated with the combination of     
zidovudine and ddC.
    DDC is the first drug approved under the principles and procedures of     
FDA's proposed accelerated drug review policy, endorsed by the White House    
Council on Competitiveness and announced by the Vice President on April 9.    
The proposal also provides for prompt removal of the drug from the market if  
further review determines the therapy to be ineffective.
    Four studies investigating the clinical usefulness of zalcitabine are     
continuing, to verify the clinical benefit of the combination therapy.
    "This new drug is not a cure," said James Mason, M.D., assistant          
secretary for health and head of the Public Health Service, "but it           
constitutes an important addition to the expanding group of antiviral drugs   
currently available, including AZT and DDI, for treating people with AIDS."
    The most severe side effects observed in individuals taking zalcitabine   
have been in the form of neurological complications, sometimes causing        
tingling and pain in the hands and feet.  In controlled clinical studies, 10  
to 12 percent of patients discontinued treatment because of these             
complications.  Other side effects included pancreatitis (inflammation of     
the pancreas), rash, oral ulcers, decreased blood platelet (blood clotting    
elements) counts and abnormal liver function.  The side effects of the        
combination of zalcitabine and zidovudine are about the same as those that    
would be anticipated with either drug, each with significant side effects     
alone.
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                                            Page 3, P92-19, ddC
    "This approval marks an important change in FDA's drug review policy,"    
said FDA Commissioner David A. Kessler, M.D.  "In this way, we can approve    
drugs that are both safe and effective as quickly as possible."
    The pharmacological action of zalcitabine, a chemically synthesized       
compound originally discovered for its antiviral activity by scientists at    
the National Institutes of Health in Bethesda, Md., appears to be its         
ability to prevent the AIDS virus from replicating or reproducing before      
T-cells (immune cells) are infected, thus preserving the cells' immune        
function.
    The drug, manufactured and distributed by Hoffmann La Roche of Nutley,    
N.J., is administered orally every eight hours in combination with AZT.       
Sold under the trade name HIVID, it is expected to be commercially available  
immediately.
    Both FDA and NIH are Public Health Service agencies within HHS.
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