Answers
03/06/1992

<TITLE>Rifabutin Receives Treatment IND Status for AIDS Related Use</TITLE>








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<PRE>

T92-12                                                Brad Stone
March 6, 1992                                         (301) 443-3285


        Rifabutin Receives Treatment IND Status for AIDS Related Use

    The Food and Drug Administration has authorized pre-approval              
distribution of rifabutin -- an experimental drug for preventing or delaying  
the onset of Mycobacterium avium complex (MAC), a severe infection that       
often afflicts AIDS patients.  The drug will be made available under a        
Treatment IND protocol which will grant access to the drug to physicians      
treating AIDS patients with seriously impaired immune systems.
    Treatment IND regulations provide a mechanism that allows FDA and drug    
developers to provide pre-approval access to experimental drugs that are      
intended to treat serious and life-threatening conditions for which there     
are no satisfactory treatments.  Drugs that are granted Treatment IND status  
must have demonstrated through clinical testing that they may be              
efficacious.  This is the 26th drug to receive Treatment IND status since     
this program was formalized in 1987.
    Individuals with MAC infection experience chronic, debilitating symptoms  
affecting many parts of the body.  Fever, weight loss, fatigue and            
gastrointestinal problems are common.  In people with AIDS, this infection    
can be fatal.  There is currently no approved treatment for MAC. 
                                   -MORE-


                                            Page 2, Rifabutin, T92-12

    The Treatment IND for rifabutin was based on two recently completed,      
large controlled clinical studies that indicate the drug may be effective in  
preventing or delaying MAC infections in AIDS patients with CD4 helper cell   
counts of 200 or less.  CD4 helper cells are white blood cells important in   
the immune system that are destroyed by the AIDS virus.  CD4 levels can be    
indicative of the state of a person's immune system.  For example, healthy    
individuals normally have CD4 helper cell counts of 1,000 or more. 
    There is no evidence from these clinical studies that the drug reduces    
or delays mortality.
    The drug will be made available under the Treatment IND to physicians     
treating patients with AIDS who have CD4 counts of 200 or less.  The drug is  
administered orally at doses of 300 milligrams a day. 
    The most serious adverse effect of rifabutin appears to be decreases in   
various types of blood cells.  Other commonly observed side-effects include   
flu-like symptoms (fever, headache, joint and muscle pain), gastrointestinal  
disorders, and rash.
    The Treatment IND for rifabutin is sponsored by the drug's developer,     
the Adria Laboratories of Dublin, Ohio.  Physicians interested in enrolling   
their patients in the Treatment IND program can contact the sponsor through   
a special hotline number, 1-800-552-7228.
</PRE>





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