Glatiramer acetate

Glatiramer acetate, sold under the brand name Copaxone among others, is an immunomodulator medication used to treat multiple sclerosis.

[1] A 2010 Cochrane review concluded that glatiramer acetate had partial efficacy in "relapse-related clinical outcomes" but no effect on progression of the disease.

Over time, a visible dent at a repeat-injection site can occur due to the local destruction of fat tissue, known as lipoatrophy, that may develop.

Metabolic and nutritional disorders have also been reported; however a link between glatiramer acetate and these adverse effects has not been established.

[1][2] Glatiramer acetate is a random polymer (average molecular mass 6.4 kDa) composed of four amino acids found in myelin basic protein.

This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental autoimmune encephalomyelitis (EAE), a condition induced in several animal species through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS. Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific regulatory T cells (Tregs) are induced and activated in the periphery, inhibiting the inflammatory reaction to myelin basic protein.

Glatiramer acetate has been shown in clinical trials to reduce the number and severity of multiple sclerosis exacerbations.

[citation needed] Novartis subsidiary Sandoz has marketed Glatopa since 2015, a generic version of the original Teva 20 mg formulation that requires daily injection.

[22] In October 2017, the FDA approved a generic version, which is manufactured in India by Natco Pharma, and imported and sold by Dutch firm Mylan.

On October 31, 2024, the European Commission fined Teva €462.6 million «over misuse of the patent system and disparagement to delay rival multiple sclerosis medicine», having attempted to obstacle other producers of glatiramer acetate both by abusing the patent system and by setting up a misinformation campaign targeting other glatiramer producers.

An injection site reaction on the upper left arm