NEWS
12/23/1992

<TITLE>The Food and Drug Administration today announced the approval of rifabutin</TITLE>








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<PRE>
P92-41                                        Food and Drug Administration
FOR IMMEDIATE RELEASE                         Monica Revelle - (301) 443-4177

    The Food and Drug Administration today announced the approval of          
rifabutin, a drug to prevent Mycobacterium avium complex (MAC) disease in     
people with advanced HIV infection.
    Rifabutin is the first drug approved for the prevention of MAC disease.   
Individuals with MAC infection experience chronic debilitating symptoms       
including fever, night sweats, weight loss, fatigue, abdominal pain, severe   
anemia and liver dysfunction.  Estimates of its prevalence in patients with   
advanced HIV infection range from 30 to 50 percent.  In people with AIDS,     
this infection can contribute to death.
    "As the first product approved for the prevention of MAC disease, this    
drug will provide significant benefits for AIDS patients," said FDA           
Commissioner David A. Kessler, M.D.  "It is a welcome addition to the         
growing number of products used to fight AIDS and diseases that can           
accompany it."
    Patients enrolled in clinical trials who received rifabutin were          
one-third to one-half as likely to develop MAC as were patients who received  
a placebo.
    The most common adverse reactions associated with rifabutin are rash,     
gastrointestinal symptoms, muscle and joint aches and discolored urine.  In   
the trials, a decrease in certain infection-fighting white blood cells was    
the only serious adverse reaction that occurred in more patients who          
received rifabutin than patients who received a placebo.
                                   -MORE-


                                                    Page 2, P92-41, Rifabutin
    Rifabutin was made available in February under a Treatment                
Investigational New Drug (IND) protocol, under which FDA allows 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 first drug whose approval was based on research from          
multi-center clinical trials conducted in community-based research groups,    
according to David W. Feigal, Jr., M.D., director of the Division of          
Anti-Viral Drug Products, which is responsible for reviewing rifabutin.       
"The approval of rifabutin marks an important medical advancement for AIDS    
patients," said Dr. Feigal.
    In September, FDA's Antiviral Drug Products Advisory Committee            
recommended approval of rifabutin.  The committee reviewed data from two      
clinical trials involving 1,146 AIDS patients whose white blood cells or CD4  
helper cell counts were 200 or less.  CD4 helper cells are white blood cells  
important in the immune system that are destroyed by the AIDS virus.
    Rifabutin is manufactured by Adria Laboratories, Columbus, Ohio, and      
will be sold under the brand name Mycobutin.
                                    ###
</PRE>





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