FDA
Enforcement Report
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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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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