FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.
 ENFORCE
01/05/1993

FDA APPROVES TREATMENT IND FOR MULTIPLE SCLEROSIS DRUG January
05, 1993


T93-1                                                Susan Cruzan
                                                     (301) 443-3285

           FDA APPROVES TREATMENT IND FOR MULTIPLE SCLEROSIS DRUG
    We are receiving inquiries about FDA's authorization of a "treatment      
IND" for the experimental drug Copolymer 1 (COP-1) for certain patients with  
multiple sclerosis (MS).  No marketed product is approved specifically for    
the treatment of this disease.  The following may be used to answer           
questions: 
    Multiple sclerosis is a central nervous system disease with highly        
variable symptoms, course and prognosis.  Among more seriously affected       
patients there may be episodes of weakness, clumsiness and visual             
disturbances from which a patient may fully or only partially recover.  In    
time, a proportion of patients may become seriously disabled, unable to       
walk, and suffer bowel and bladder problems. 
    FDA's treatment IND regulations offer a mechanism that allows drug        
developers to provide earlier and wider access to promising investigational   
therapies, such as COP-1, for patients with serious or immediately            
life-threatening diseases for which there is no satisfactory alternative      
treatment.
    A study has suggested that COP-I may be able to reduce the frequency of   
acute episodes experienced by some patients with exacerbating-remitting MS, 
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                                            Page 2, T93-1, COP-1
a type of MS that consists of relapses followed by remissions.  The study     
reported that 50 patients given daily injections of COP-1 over a period of    
two years had fewer relapses than those given a placebo.
    Side effects associated with the use of COP-1 are not ordinarily          
troublesome and are generally tolerated by most patients.  In just a few      
cases, patients experienced temporary sweating, rapid heartbeat and           
difficulty in breathi