Enduring Clinical Value of Copaxone® (Glatiramer Acetate) in Multiple Sclerosis after 20 Years of Use

Abstract

Multiple sclerosis (MS) is a chronic progressive neurodegenerative demyelinating disease affecting the central nervous system. Glatiramer acetate (GA; Copaxone®) was the first disease-modifying treatment (DMT) for MS successfully tested in humans (1977) and was approved by the US Food and Drug Administration in December 1996. Since then, there have been numerous developments in the MS field: advances in neuroimaging allowing more rapid and accurate diagnosis; the availability of a range of DMTs including immunosuppressant monoclonal antibodies and oral agents; a more holistic approach to treatment by multidisciplinary teams; and an improved awareness of the need to consider a patient's preferences and patient-reported outcomes such as quality of life. The use of GA has endured throughout these advances. The purpose of this article is to provide an overview of the important developments in the MS field during the 20 years since GA was approved and to review clinical data for GA in MS, with the aim of understanding the continued and widespread use of GA. Both drug-related (efficacy versus side-effect profile and monitoring requirements) and patient factors (preferences regarding mode of administration and possible pregnancy) will be explored.

Figure 1

Timeline of approval by the FDA of disease-modifying therapies for multiple sclerosis. FDA: Food and Drug Administration; IM: intramuscular; SC: subcutaneous. ^aInterferon beta-1b was also approved in 2009 as Extavia® (which is the Novartis-branded version of the Bayer product Betaseron®). ^bVarious generic versions of glatiramer acetate are in development. Glatopa™ [10] was approved in 2015 by the FDA. Other generic versions were approved in the EU in 2016 and by the FDA in 2017 [11, 12]. ^cBioequivalent generic mitoxantrone was approved in 2006. ^dSubsequently withdrawn (March 2018).

Box 1

Summary of characteristics of branded glatiramer acetate in MS. ARR: annualized relapse rate; DMT: disease-modifying treatment; GA, branded glatiramer acetate; IFN: interferon; MS: multiple sclerosis; PML: progressive multifocal leukoencephalopathy.