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Glatiramer

Generic Name
Glatiramer
Brand Names
Copaxone, Glatect, Glatopa
Drug Type
Biotech
CAS Number
28704-27-0
Unique Ingredient Identifier
U782C039QP
Background

Glatiramer acetate is a mix of synthetic polypeptides that includes L-glutamic acid, L-alanine, L-tyrosine, and L-lysine at an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. Since glatiramer acetate is a heterogeneous drug, there is limited information about its physicochemical properties. Originally, glatiramer acetate was designed as a stimulant of myelin basic protein (MBP), a myelin antigen involved in the development of multiple sclerosis (MS), to induce experimental autoimmune encephalitis (MS animal model). However, the opposite was observed. Glatiramer acetate exhibits several immunomodulatory effects and reduces the relapse rate of relapsing-remitting multiple sclerosis (RRMS) by 30%. Along with human interferon beta, teriflunomide, and dimethyl fumarate, glatiramer acetate is a first-line drug for patients with MS. It was approved by the FDA in 1996, and a generic version became available in 2017.

Indication

Glatiramer acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Associated Conditions
Clinically Isolated Syndrome (CIS), Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)
Clinical Trials
Related News

GA Depot Shows Promise in Progressive MS with 3-Year Stability in Disability Scores

• Phase 2 study results demonstrate GA Depot's safety profile in progressive MS patients, with stable EDSS scores maintained over three years and minimal disability progression. • The long-acting, monthly treatment showed encouraging efficacy with 69% of patients exhibiting no evidence of progression and high stability rates in mobility and hand function tests. • Treatment was well-tolerated with predominantly mild adverse events, particularly at the 25mg dose, supporting advancement to a global phase 3 trial.

FDA Adds Boxed Warning to Glatiramer Acetate for Anaphylaxis Risk

• The FDA has issued a boxed warning for glatiramer acetate, a multiple sclerosis drug, due to the risk of anaphylaxis. • The warning applies to both brand-name (Copaxone) and generic versions (Glatopa) of the medication. • Anaphylaxis can occur at any time during treatment, even after months or years of use, and may require hospitalization. • Healthcare providers are advised to educate patients on anaphylaxis symptoms and the need for immediate medical attention.

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. • Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). • Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. • Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.

FDA Approves Mylan's Generic Versions of Copaxone for Multiple Sclerosis Treatment

• The FDA has approved Mylan's glatiramer acetate injections in two dosage forms (40 mg/mL three-times-weekly and 20 mg/mL once-daily) as therapeutically equivalent alternatives to Teva's Copaxone for relapsing forms of multiple sclerosis. • Mylan's generic versions demonstrated the same active ingredient, dosage form, route of administration, and strength as Copaxone, allowing them to be substituted with comparable safety and efficacy profiles. • Alongside the medication launch, Mylan introduced the comprehensive MS Advocate support program offering injection training, 24/7 patient support, co-pay assistance, and ongoing nurse support to help patients adhere to their treatment plans.
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