Glatect™ (glatiramer acetate) 20mg
Drug identification number (DIN): 02460661
Glatect is a synthetic protein made up of a combination of four amino acids that chemically resemble a component of myelin (the insulating material that protects nerves and helps them work properly). Glatect induces the production of immune cells that are less damaging to myelin.
Indications and use
Glatect (glatiramer acetate injection) is indicated for
treatment of ambulatory patients with Relapsing Remitting
Multiple Sclerosis (RRMS), including patients who have
experienced a single demyelinating event and have lesions
typical of multiple sclerosis on brain MRI:
-To decrease the frequency of clinical exacerbations.
-To reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans.
The safety and efficacy of Glatect in chronic progressive MS have not been established.
Before Glatect is initiated, people at risk of developing CDMS must have brain lesions on MRI and other possible diagnoses must be ruled out.
Glatect is contraindicated in people who are hypersensitive to this drug, to any ingredient in the formulation or component of the container.
Administration and dose
Glatect 20mg is self-injected every day under the skin (subcutaneously). Glatect is available in pre-filled syringes. The recommended dose of Glatect is 20mg per day.
Mechanism of action
Glatect is a mixture of peptides (or small proteins) that resemble a protein in myelin. Glatect is thought to work by modifying the immune processes that are believed to cause MS.
The most common side effects of Glatect therapy are injection-site reactions (redness, pain, inflammation, itching, or a lump. A permanent depression under the skin at the injection site may also occur, due to a destruction of fat tissue (lipoatrophy) at that site. Rash and hives, headache and anxiety can also occur. This is not a comprehensive list of all possible side effects of Glatect.
Please see the Glatect product monographfor a list of other potentially serious side effects. It is important that those with MS discuss side effects about any medication they are considering with their physician. (*Health Canada, product monograph for Glatect.)
Clinical Trials in Relapsing-Remitting MS
Glatect was evaluated in a multi-center, pivotal, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial (GATE) comparing the efficacy, safety and tolerability of Glatect 20mg to Copaxone® 20mg in patients with RRMS. This was followed by 15 months of open-label treatment with Glatect to evaluate the long-term safety and efficacy. The primary objective in the double-blind phase was to demonstrate that the efficacy of Glatect is equivalent to Copaxone® as measured by the number of gadolinium-enhancing (GdE) lesions on T1-weighted MRIs during Months 7 to 9. Results of GATE found that Glatect and Copaxone have equivalent efficacy, safety, and tolerability.
Prior to the GATE trial, the efficacy of another glatiramer acetate product was evaluated in two placebo-controlled trials in patients with relapsing remitting MS (Trial BR-1 and 01-9001). In a third placebo-controlled study (9003) the effects of glatiramer acetate on MRI parameters were assessed. Information related to these studies can be found in the product monograph for Glatect.
Clinical Trial in Early MS
The GA/9010 study was a multicenter, randomized, double-blind, placebo-controlled, parallel group study involving 481 patients who were treated with glatiramer acetate 20 mg/day or placebo for up to three years. It was performed in patients with a well-defined, single, unifocal neurological presentation and with at least two cerebral lesions on T2-weighted MRI. The primary outcome measure in the study was the time to development of a second exacerbation according to Poser criteria. Secondary outcomes were brain MRI measures including number of new T2 lesions and T2 lesion volume. Results of the study found that time to development of a second exacerbation was significantly delayed in the glatiramer acetate group compared with the placebo group.
Glatect is currently being evaluated by the Canadian Agency of Drugs and Technologies in Health (Common Drug Review) who will provide a recommendation for provincial public plan coverage for all Canadian provinces except Quebec. The Institut national d’excellence en sante et en services sociaux (INESSS) in Quebec conducts an independent review.
Drug Support Program
ALLY Patient Support Program: 1-833-ALLY100
1. Cohen J., Belova A., Selmaj K., Wolf C., Sormani M.P., Oberyé
J., van den Tweel E., Mulder R., Koper N., Voortman G., Barkhof
F. Equivalence of Generic Glatiramer Acetate in Multiple
Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2015 Oct
2. Selmaj K, Barkhof F, Belova AN, Wolf C, van den Tweel ER, Oberyé JJ, Mulder R, Egging DF, Koper NP, Cohen JA; GATE study group. Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results. Mult Scler. 2017
Glatect is a trademark of Pharmascience Inc.