Date: 2015-04-28
Type of information: Results
phase: 3
Announcement: results
Company: Synthon (The Netherlands)
Product: Synthon GTR (glatiramer acetate)
Action
mechanism: peptide. Glatiramer acetate is a mixture of synthetic polypeptides composed of four amino acids resembling the myelin basic protein.
Disease: relapsing remitting multiple sclerosis
Therapeutic area: Neurodegenerative diseases
Country:
Trial
details: GATE was set up following Scientific Advice received from the European Medicines Agency (EMA) with the aim to show equivalence of Synthon’s glatiramer acetate (Synthon GTR) with Teva’s Copaxone® in a well-controlled 3-arm double-blind equivalence study. The open-label part of the study further aimed to provide 2-year efficacy, safety and tolerability data on Synthon’s generic glatiramer acetate and to show safety of switching from Copaxone® to Synthon’s generic. The large-scale, multicenter study consisted of a nine-month double-blind efficacy comparison followed by a 15-month open-label extension and was executed in RRMS patients in Europe (including Russia, Ukraine and Belarus), Mexico, South Africa and the United States.
Latest
news: * On April 28, 2015, Synthon announces that data from the open-label extension of the Phase III GATE study of the Company’s generic glatiramer acetate in patients with relapsing remitting multiple sclerosis (RRMS) demonstrate that efficacy, safety and tolerability were maintained over the entire two-year study period. The data further support the safety of switching from Copaxone® to Synthon’s glatiramer acetate. Following the nine month double-blinded period of the GATE study, in which 796 patients were treated with Synthon’s generic glatiramer acetate (GTR), Copaxone® or placebo, patients initially treated with Synthon GTR continued their treatment for an additional 15 months to complete the planned two-year study period. Patients from the Copaxone® and placebo groups were successfully switched over to treatment with Synthon GTR for a 15-month period. Results from this part of the study confirmed continued efficacy, measured by MRI parameters and clinical relapses, as well as the continued safety and tolerability during a two-year treatment period with Synthon GTR. The data further support the safety of switching active therapy from Copaxone® to Synthon’s generic glatiramer acetate. Efficacy, safety and tolerability profiles remained unaffected throughout the duration of the extension study. Synthon announced results from the GATE study in March 2014 demonstrating that Synthon’s glatiramer acetate had an efficacy and safety profile that was equivalent to Copaxone®. The open-label data will provide further support for the evaluation of Synthon’s glatiramer acetate by regulatory authorities, prescribing neurologists and payers. Full details of the study will be submitted for publication in a peer-reviewed medical journal and presented at future scientific meetings.
