Glatiramer Acetate

Glatiramer Acetate

Evidence & Status

  • FDA Approved
  • Strong Human Evidence
  • Established

FDA Approval Scope

U.S. approval: treatment of relapsing forms of MS in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

At a Glance

An FDA-approved injectable medicine for adults with relapsing forms of multiple sclerosis. It is a mixture of polypeptides and carries a boxed warning for anaphylaxis.

Plain English

Glatiramer acetate is an established MS medicine sold under names including Copaxone and Glatopa. It can reduce relapses in the groups studied. It is not a general focus or memory supplement, and a rare, severe allergic reaction can occur even after years of use.

Overview

Glatiramer acetate is a heterogeneous mixture of synthetic polypeptides containing glutamic acid, alanine, tyrosine, and lysine. In the United States, glatiramer acetate products are approved for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Its therapeutic mechanism is not fully understood.

Research Summary

Evidence for Copaxone includes randomized placebo-controlled studies of relapsing MS. In a 12-month study of 1,404 participants, the adjusted annualized relapse rate was 0.331 with the studied 40 mg/mL regimen versus 0.505 with placebo. This finding establishes a reduction in relapses in the studied population; that trial did not establish a benefit for long-term disability progression.

Research Areas

  • Relapsing multiple sclerosis
  • Relapse reduction
  • Immune-system research

Safety & Risks

Serious Risks

  • Life-threatening or fatal anaphylaxis can occur after the first injection or years after treatment begins.
  • Lipoatrophy and skin necrosis have been reported at injection sites.
  • Severe liver injury, including liver failure, has been reported.

Reported Side Effects

  • Injection-site reactions
  • Flushing
  • Transient chest pain
United States
FDA-approved glatiramer acetate products treat relapsing forms of MS in adults; indications and dosing depend on the product label.
United Kingdom
Copaxone is a prescription medicine indicated for relapsing forms of MS.
Australia
Copaxone glatiramer acetate injection is registered; product presentations may differ.
Canada
Copaxone glatiramer acetate injection is marketed; consult its Canadian product monograph for local indications.

Citations & Sources