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A Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to Placebo

Trial Profile

A Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to Placebo

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2024

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At a glance

  • Drugs Glatiramer acetate (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Mapi Pharma; Mylan

Most Recent Events

  • 18 Apr 2024 Results assessing Safety and Tolerability Features of GA Depot , presented at the 76th Annual Meeting of the American Academy of Neurology 2024
  • 11 Mar 2024 According to a Mapi Pharma media release, Viatris Inc. has been informed that Mapi Pharma Ltd. has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40 mg from the U.S. Food and Drug Administration (FDA). The Companies are reviewing the content of the CRL and will be determining the appropriate next steps.
  • 02 Mar 2024 Results (n=821) assessing the safety and tolerability of GA Depot in a one-year, OL period for patients that previously had completed the 52-week PC period, presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2024.

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