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Positive Results Published from 9-Month Clinical Trial of a Generic Glatiramer Acetate in Relapsing-Remitting MS

October 16, 2015

  • In a nine-month study of 794 people with relapsing-remitting MS, GTR (generic glatiramer acetate, Synthon BV) reduced disease activity on MRI scans similarly to Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries Ltd).
  • This study has been published in JAMA Neurology (Published Online October 12, 2015).
  • An April 28, 2015 press release notes that safety and effectiveness were maintained over two years in an extension study, results of which have not yet been published.
  • Synthon has filed Abbreviated New Drug Applications with the U.S. FDA for approval of GTR as a generic glatiramer acetate.

Background: Glatiramer acetate is a synthetic compound that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. Currently glatiramer acetate is available as Copaxone and is approved by the FDA to reduce the frequency of relapses in patients with relapsing-remitting MS and for use in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with MS.

In April 2015, a generic equivalent of Copaxone called “Glatopa”™ (Sandoz, a Novartis company, developed in collaboration with Momenta Pharmaceuticals) was approved by the FDA.

This study compared another generic version of glatiramer acetate with Copaxone.

The Study: Participants were randomly assigned to receive GTR (20 mg/day injected under the skin), Copaxone (20 mg/day injected under the skin), or inactive placebo (injected daily under the skin) for 9 months.

The primary goal of the study was to compare the number of active MS lesions on MRI brain scans in those who were given GTR, Copaxone, or placebo during months 7, 8, and 9.  The results show that this MRI measure of disease activity was significantly reduced in both the Synthon GTR and the Copaxone groups when compared with the placebo group within a range that indicates equivalence. Reported adverse reactions were similar between the GTR and Copaxone groups and in line with injection site reactions and others known to be associated with Copaxone.

The results were announced in a March 27, 2014 press release from Synthon BV and have now been published in JAMA Neurology (Published Online October 12, 2015).

Next Steps: In an ongoing extension study, participants in any of the groups who completed the first 9 months were being treated with GTR (20 mg/day) for 15 months. An April 28, 2015 press release notes that safety and effectiveness were maintained over the entire two-year period, but full details will be submitted for publication in a peer-reviewed medical journal and presented at future scientific meetings.

In November 2011, Synthon filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for a once daily 20mg/ml formulation of marketing approval of GTR as a generic equivalent to glatiramer acetate. In early 2014, the company filed an application for a three times a week, 40mg/ml formulation.

“We look forward to hearing the results of the FDA’s determination of the equivalence of this medication,” says Dr. Bruce Bebo, Executive Vice President, Research at the National MS Society. “Generic options can help to increase access to comprehensive, quality healthcare for everyone living with MS.”

Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
Glatopa is a trademark of Novartis AG

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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