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Copaxon approved.


A third drug has been approved for marketing in the United States as a therapy for people with relapsing-remitting MS. Copaxone or copolymer 1 (now known generically as glatiramer acetate for injection) is a synthetic protein that simulates myelin basic protein Myelin basic protein (MBP) is a protein believed to be important in the process of myelination of nerves in the central nervous system (CNS).

MBP was initially sequenced in 1979 after isolation from myelin membranes [1]
, a component of the material called myelin myelin /my·elin/ (mi´e-lin) the lipid-rich substance of the cell membrane of Schwann cells that coils to form the myelin sheath surrounding the axon of myelinated nerve fibers.  that insulates nerve fibers in the brain and spinal cord. It is myelin that is damaged in MS. Although scientists don't yet understand exactly how Copaxone works, the best guess is that the substance is a kind of decoy to attacking immune cells.

The data that prompted FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval was garnered in a randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind, controlled trial involving 251 volunteers at 11 U.S. medical centers along with an earlier, smaller trial. These data showed the annual rate of relapses was reduced by 29% in people who took Copaxone as compared to people who took a placebo, or inactive look-alike.

All the volunteers had active relapsing-remitting MS with disability rated "minimal" to "moderate". ("Moderate" or, technically, #5 of the 10 points on the Expanded Disability Status Scale The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis.[1] The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these.  used to rate MS disability, means a person has significant problems with daily activities but can walk without an aid at least 200 meters.)

With the approval of Copaxone, people with relapsing-remitting MS have a choice among three relatively nontoxic drugs -- all of which have a proven effect on the natural course of MS.
COPYRIGHT 1997 National Multiple Sclerosis Society
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1997, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Title Annotation:for multiple sclerosis care
Publication:Inside MS
Date:Mar 22, 1997
Words:229
Previous Article:Running with MS. (multiple sclerosis)(You & Me)(Column)
Next Article:Treatment options - now there are three. (for multiple sclerosis)(includes related information)
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