Drugs / Glatiramer Acetate
Glatiramer Acetate
also known as
Copaxone · COP-1 · Copaxone (glatiramer acetate) · Copaxone (Glatiramer acetate, COP, Copolymer-1) · copolymer 1 · GA Depot · Glatopa · Glatopa (glatiramer acetate) · +1 more
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed relapsing-remitting multiple sclerosis 2 milestones | |||||
| Filed | US (FDA) | — | relapsing-remitting multiple sclerosis | 2023-08-07 | “Following successful Phase 3 results GA Depot was submitted for registration and is currently under FDA review.” mapi-pharma.com ↗ “FDA has accepted for review the companies’ recently submitted New Drug Application (NDA) for GA Depot 40 mg.” mapi-pharma.com ↗ |
| Filed | US (FDA) | COPAXONE® | relapsing-remitting multiple sclerosis | 2013-05-30 | “FDA has accepted for review the company’s supplemental new drug application (sNDA) for COPAXONE® (glatiramer acetate injection) 40mg/ 1mL” tevapharm.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | COPAXONE | — | 2009-02-27 – 2014-01-28 | fda.gov ↗ |
| Filed | EU (EMA) | Copaxone | — | 2001-05-02 | “In Europe, Copaxone ® has been submitted for filing under the Mutual Recognition Process.” tevapharm.com ↗ |
| Approved | US (FDA) | COPAXONE | — | 1996-12-20 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03982212 | Jul 2019 → Dec 2022 | basal cell carcinoma, skin squamous cell carcinoma | University of Kansas Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT02023424 | Jan → Sep 2014 | Rett syndrome | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02212886 | Oct 2014 → May 2017 | multiple sclerosis | Mapi Pharma Ltd. | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07851337 | Dec 2026 → Dec 2028 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06003972 | Jan 2021 → Mar 2023 | cytokine release syndrome, heart failure, inflammatory disease | Hadassah Medical Organization | Completed | No outcome recorded |
| Phase 2 | NCT03362294 | Dec 2017 → Jun 2025 | primary progressive multiple sclerosis | Mapi Pharma Ltd. | Terminated | No outcome recorded |
| Phase 2 | NCT02153723 | Aug 2013 → Aug 2014 | Rett syndrome | Montefiore Medical Center | Completed | Met primary |
| Phase 2 | NCT00939549 | Nov 2010 | relapsing-remitting multiple sclerosis | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00731172 | Sep 2008 → Jul 2010 | Crohn disease | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT00326625 | Jul 2006 → Jun 2008 | amyotrophic lateral sclerosis | Teva Pharmaceutical Industries, Ltd. | Completed | Missed primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03315923 | Dec 2017 → Feb 2019 | secondary progressive multiple sclerosis | Isfahan University of Medical Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT00466076 | Aug 2006 → Apr 2007 | macular degeneration | Kaplan Medical Center | Unknown | No outcome recorded |
| Phase 39 trials · 5 met primary | ||||||
| Phase 3 | NCT07189325 | Jun 2026 → Jun 2031 expected | relapsing-remitting multiple sclerosis | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 3 | NCT04121221 | Sep 2019 → Jun 2023 | relapsing-remitting multiple sclerosis | Mapi Pharma Ltd. | Completed | Met primary |
| Phase 3 | NCT01578785 | Mar → Oct 2012 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01489254 | Oct 2011 → Jan 2015 | multiple sclerosis | Synthon BV | Completed | Met primary |
| Phase 3 | NCT01067521 | Jun 2010 → May 2012 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT00947752 | Jul → Sep 2009 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00856635 | Feb 2009 → Dec 2010 | optic neuritis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00666224 | Jan 2004 → Oct 2007 | multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT00004814 | Oct 1991 → ? | multiple sclerosis | National Center for Research Resources (NCRR) | Completed | Met primary |
| Phase 48 trials · 2 met primary | ||||||
| Phase 4 | NCT04878211 | Jun 2021 → Apr 2023 | multiple sclerosis | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02499900 | Aug 2015 → Jan 2017 | multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 4 | NCT01216072 | Aug 2010 → Aug 2012 | multiple sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT00910598 | Sep 2009 → Jun 2012 | multiple sclerosis | Amphia Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00202995 | Jul 2004 → Oct 2007 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00267319 | Jun 2003 → Oct 2006 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00203021 | Mar 1994 → Feb 2018 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase not applicable3 trials · 1 missed | ||||||
| — | NCT04260711 | Jul 2020 → Aug 2023 | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Amsterdam UMC, location VUmc | Unknown | Missed primary |
| — | NCT00937157 | Sep 2007 → Jul 2010 | multiple sclerosis | University at Buffalo | Completed | No outcome recorded |
| — | NCT00331747 | May 2006 → ? | multiple sclerosis | Sheba Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy38 trials | ||||||
| Phase 1 | NCT00541333 Comparator | Dec 2007 → Dec 2012 | dry age related macular degeneration | The New York Eye & Ear Infirmary | Suspended | No outcome recorded |
| Phase 2 | NCT06715605 Comparator | Apr 2025 | multiple sclerosis | University Hospital, Antwerp | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04079088 Background | Jun 2021 → Sep 2024 | multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
| Phase 2 | NCT01963611 Comparator | Oct 2013 → Mar 2015 | relapsing-remitting multiple sclerosis | EMD Serono | Terminated | No outcome recorded |
| Phase 2 | NCT01569451 Background | Feb 2012 → May 2015 | multiple sclerosis | University of Colorado, Denver | Completed | Met primary |
| Phase 2 | NCT01071083 Comparator | Mar 2010 → Nov 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00811395 Background | Oct 2007 → Apr 2010 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00475865 Background | Apr 2007 → Oct 2009 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00451204 Comparator | Mar 2007 → Jul 2014 | relapsing-remitting multiple sclerosis | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2 | NCT00273364 Comparator | Nov 2005 → Jan 2017 | multiple sclerosis | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT00203099 Comparator | Dec 2004 → Aug 2006 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00203112 Background | Jun 2004 → Jun 2006 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00202982 Comparator | Aug 2003 → Sep 2005 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00203073 Comparator | Jun 2003 → Jan 2005 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00097760 Background | Jun 2003 → Mar 2004 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT06663189 Comparator | Jan 2025 → Jan 2027 expected | relapsing-remitting multiple sclerosis | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04788615 Comparator | Jul 2021 → Nov 2025 | multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03368664 Background | Oct 2017 → May 2021 | multiple sclerosis | Genzyme, a Sanofi Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01874145 Comparator | Jun 2013 → Apr 2014 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01633112 Comparator | Aug 2012 → Apr 2018 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01936129 Comparator | Sep 2010 → Oct 2013 | acute closed-angle glaucoma | Singapore Eye Research Institute | Unknown | No outcome recorded |
| Phase 3 | NCT01167426 Comparator | Jul → Nov 2010 | multiple sclerosis | Teva Neuroscience, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01058005 Comparator | Mar 2010 → Apr 2012 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00451451 Comparator | Jun 2007 → Aug 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 3 | NCT00337779 Comparator | Aug 2006 → Oct 2008 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00211887 Comparator | Jan 2005 → Apr 2012 | relapsing-remitting multiple sclerosis | Fred Lublin | Completed | No outcome recorded |
| Phase 3 | NCT00099502 Comparator | Nov 2003 → Aug 2007 | relapsing-remitting multiple sclerosis | Bayer | Completed | Missed primary |
| Phase 4 | NCT04792567 Comparator | Apr → Sep 2021 | secondary progressive multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01623596 Comparator | Jun 2012 → Jul 2015 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01534182 Comparator | Jan 2012 → Jun 2013 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01317004 Comparator | May 2011 → Jun 2014 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00677664 Comparator | Jul 2006 → Jul 2008 | diabetic retinopathy | Federal University of São Paulo | Unknown | No outcome recorded |
| Phase 4 | NCT00239993 Background | Aug → Dec 2005 | multiple sclerosis | Teva Neuroscience, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00203047 Background | Jan 2005 → May 2009 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT00240032 Comparator | Oct 2004 → Jun 2006 | multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00078338 Comparator | Feb 2004 → Nov 2006 | relapsing-remitting multiple sclerosis | EMD Serono | Completed | Missed primary |
| Phase 4 | NCT00176592 Comparator | Jan 2003 → Jan 2007 | multiple sclerosis | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
| — | NCT00039988 Background | Nov 2001 → Mar 2006 | multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 96
| Date | Issuer | Release |
|---|---|---|
| 2026-04-16 | Mapi Pharma Ltd. | Results Mapi Pharma to Present Efficacy (EDSS) Data from Glatiramer Acetate Depot Long-Acting Injection Studies in Relapsing Forms of Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS) at AAN 2026 mapi-pharma.com ↗
In the above studies in PPMS and RMS, GA Depot showed EDSS stabilization, irrespective of baseline EDSS scores. |
| 2026-02-03 | Mapi Pharma Ltd. | Results Mapi Pharma to Present New Safety and Efficacy Data from Glatiramer Acetate Depot Long-Acting Injection Phase II Study in Patients with Primary Progressive Multiple Sclerosis (PPMS) at ACTRIMS Forum 2026 mapi-pharma.com ↗
The new clinical results we are sharing this week at ACTRIMS demonstrate that GA Depot can significantly impact disease progression. |
| 2025-05-09 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Glatiramer Acetate Injection zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes. |
| 2023-10-10 | Mapi Pharma Ltd. | Results Mapi Pharma to Present Plans for Additional Studies of GA Depot in Multiple Sclerosis and Other Indications and Highlights Latest Results on GA Depot in Relapsing Multiple Sclerosis at the ECTRIMS-ACTRIMS® Meeting in Milan, Italy October 11-13, 2023 mapi-pharma.com ↗
The data presented at this year’s ECTRIMS-ACTRIMS Congress (MS Milan) show that GA Depot has a favorable safety and tolerability profile compared to daily or thrice weekly GA formulations and may have a safety advantage compared to available treatments. |
| 2023-08-07 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis viatris.com ↗ |
| 2023-08-07 | Mapi Pharma Ltd. | Regulatory Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis mapi-pharma.com ↗
Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Mapi Pharma Ltd., a fully integrated, late-stage clinical development pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ recently submitted New Drug Application (NDA) for GA Depot 40 mg. |
| 2023-04-24 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Results Viatris and Mapi Pharma to Highlight Latest Results of Multiple Sclerosis Research at American Academy of Neurology 75th Annual Meeting viatris.com ↗
Data will include results from the pivotal Phase III clinical trial exploring the efficacy and safety of GA Depot – a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS). |
| 2022-09-21 | Mapi Pharma Ltd. | Results Mapi Pharma Announces Positive Top-Line Results from GA Depot Phase III Trial for Relapsing forms of Multiple Sclerosis (RMS) mapi-pharma.com ↗
The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate (ARR) by 30.1 percent compared to placebo (p=0.0066) |
| 2022-05-31 | Mapi Pharma Ltd. | Results Mapi Pharma to Present Late Breaking Poster Presentation on GA Depot for Treating Primary Progressive Forms of Multiple Sclerosis at CMSC 2022 Annual Meeting mapi-pharma.com ↗
We are very pleased to have the opportunity to share the 1-year snapshot data on our GA Depot from the Phase IIa study for PPMS at this year’s CMSC conference. |
| 2022-02-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory COPAXONE® Label Now Indicates Its Use in Breastfeeding Mothers with Relapsing Multiple Sclerosis tevapharm.com ↗
The product is now approved by EU health authorities for use in breastfeeding. |
| 2021-10-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis tevapharm.com ↗
Maternal pregnancy and breastfeeding exposure to GA in this study did not adversely affect offspring with regard to hospitalisations and antibiotic treatments, developmental delay, or growth in the first 18 months of life |
| 2021-10-13 | Biogen | Results New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis biogen.com ↗
For all other classes evaluated in the analysis, including the broad range of MS therapies offered by Biogen, the antibody response to vaccination is consistent with the response of patients not being treated with an MS disease-modifying therapy (DMT). |
| 2021-06-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis: COBRA study presented at the 7th Congress of the European Academy of Neurology (EAN) tevapharm.com ↗
It concluded that no evidence exists to suggest that infants were adversely affected by maternal exposure to glatiramer acetatewhile breastfeeding with regard to hospitalisations and antibiotic treatments, developmental delay, or growth in the first 18 months of life1. |
| 2020-09-10 | Mapi Pharma Ltd. | Results Mapi Pharma Presents Glatiramer Acetate Depot (GA Depot) Results at the 8th Joint ACTRIMS-ECTRIMS Meeting MSVirtual2020 mapi-pharma.com ↗
Mean Expanded Disability Status Scale (EDSS) score after four years showed no change compared to baseline. |
| 2019-09-11 | Biogen | Results New Data Presented at ECTRIMS Reinforce Long-term Benefits of TECFIDERA® (dimethyl fumarate) Over 10 Years biogen.com ↗
The meta-analysis analyzed data from 18 databases of large real-world studies and found that TECFIDERA was significantly more effective than interferon beta, glatiramer acetate and teriflunomide in reducing annualized relapse rate and delaying time to first relapse. |
| 2019-09-04 | Mapi Pharma Ltd. | Results Mapi Pharma to Present Series of Recent Advancements for Treating Multiple Sclerosis (MS) at ECTRIMS 2019 mapi-pharma.com ↗
The continued strong results of GA Depot for both RRMS and PPMS demonstrate the product’s safety, tolerability, and efficacy in MS patients. |
| 2019-05-10 | Novartis Pharmaceuticals | Results Novartis data at AAN show Gilenya® is the first and only disease-modifying therapy with proven superiority versus glatiramer acetate in relapsing remitting MS novartis.com ↗
Gilenya showed significant superiority versus glatiramer acetate in other key measures of disease activity, such as brain lesions[1] |
| 2018-10-10 | Novartis Pharmaceuticals | Results Novartis announces new data from the first direct head-to-head trial to demonstrate superior efficacy of Gilenya® over Copaxone® in patients with relapsing remitting multiple sclerosis novartis.com ↗
The data show that Gilenya 0.5mg met its primary endpoint of significantly reducing the annualized relapse rate (ARR) compared to Copaxone[1]. |
| 2018-10-09 | Mapi Pharma Ltd. | Results Mapi Pharma Presents Phase II Extension Results of Glatiramer Acetate Depot (GA Depot) at ECTRIMS 2018 in Berlin mapi-pharma.com ↗
Eighty-one point eight percent (81.8%) of PPP patients achieved NEDA (No Evidence of Disease Activity) at two years. |
| 2018-10-02 | Biogen | Results Biogen Highlights at ECTRIMS 2018 Data on Its Industry-Leading Multiple Sclerosis Portfolio and a Range of Initiatives Aimed at Transforming Patient Care biogen.com ↗
In a propensity score matching analysis of data from ADVANCE and CONFIRM, PLEGRIDY showed better clinical outcomes compared to glatiramer acetate. |
| 2018-04-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Long-Term Data Demonstrating Efficacy and Safety of COPAXONE® (glatiramer acetate injection) 40 mg/mL tevapharm.com ↗
Results show that favorable annualized relapse and disability progression rates are observed in both patients continuing COPAXONE® 40 mg/mL and patients switching from placebo to COPAXONE® 40 mg/mL. |
| 2018-02-13 | Novartis Pharmaceuticals | Regulatory Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis novartis.com ↗
today announced the US FDA approval and launch of Glatopa ® (glatiramer acetate injection) 40 mg/mL. |
| 2017-10-31 | Mapi Pharma Ltd. | Results Mapi Pharma Announces Presentation of Phase II Results of Glatiramer Acetate Depot at ECTRIMS-ACTRIMS 2017 Congress in Paris mapi-pharma.com ↗
The study achieved the primary endpoint for safety and tolerability. |
| 2017-10-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Comments on Anticipated At-Risk U.S. Launch of Generic Glatiramer Acetate 40mg/mL and Launch of Generic Glatiramer Acetate 20mg/mL tevapharm.com ↗
Additionally, Mylan also announced approval of a generic glatiramer acetate 20mg/mL. |
| 2017-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Publication of COPAXONE® (glatiramer acetate injection) Pregnancy Data in the International Journal of MS Care tevapharm.com ↗
These data appeared as an “Online First” article on the Website of the International Journal of MS Care (IJMSC) and represent the largest published analysis of pregnancy pharmacovigilance data for an RMS treatment. |
| 2016-12-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Positive Outcome for COPAXONE® Label in Europe tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that it has received a positive outcome through the variation procedure to remove the pregnancy contraindication from the European label for COPAXONE® (glatiramer acetate injection) 20 mg/mL. |
| 2016-09-14 | Biogen | Results New Data Affirm Strong Efficacy and Well-Characterized Safety Profile of TECFIDERA® in Both Clinical Studies and Real-World Setting biogen.com ↗
TECFIDERA Treatment Significantly Reduced Time to First Relapse vs. Glatiramer Acetate, Interferon β and Teriflunomide and Showed Comparable Efficacy to Fingolimod in Data Analysis from MSBase Registry |
| 2016-08-23 | Teva Canada | Regulatory Teva Canada Innovation Announces Approval of Three-Times-a-Week COPAXONE® 40mg/mL by Health Canada tevacanada.com ↗
Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries Ltd., announced today that Health Canada has approved three-times-a-week COPAXONE® (glatiramer acetate) 40 mg/mL injection. |
| 2016-02-02 | Theriva Biologics, Inc. | Results Synthetic Biologics Reports Results of Independent Third Party Evaluations of Trimesta™ Data from Investigator-Sponsored Phase 2 Clinical Trial for Relapsing-Remitting Multiple Sclerosis therivabio.com ↗
Both the clinical and magnetic resonance imaging (MRI) results from the independent analyses did not demonstrate statistically significant differences between the Trimesta plus Copaxone treatment group compared to the Copaxone plus placebo group at either 12 or 24 months. |
| 2015-10-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Three-Times-A-Week COPAXONE® 40 mg/mL in Russia for the Treatment of Relapsing-Remitting Multiple Sclerosis tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Russian Ministry of Health has approved the Marketing Authorization license (MA) for three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg/mL, a new dose of COPAXONE®, for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). |
| 2015-09-28 | Takeda | Regulatory New Drug Application Approval in Japan for Copaxone ® Subcutaneous Injection 20 mg Syringe, a Drug for the Treatment of Multiple Sclerosis takeda.com ↗
Takeda Pharmaceutical Company Limited (TSE:4502) today obtained the New Drug Application approval for Copaxone ® Subcutaneous Injection 20 mg Syringe (generic name: glatiramer acetate), a drug for the treatment of multiple sclerosis, from the Japanese Ministry of Health, Labour and Welfare. |
| 2015-09-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of COPAXONE® in Japan for the Prevention of Relapse of Multiple Sclerosis tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) announced today the approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) of once-daily COPAXONE® (glatiramer acetate injection) 20mg injection for the prevention of relapse of multiple sclerosis . |
| 2015-04-23 | Novartis Pharmaceuticals | Regulatory Novartis delivered sales growth (cc), significant margin expansion (cc) and strong innovation in Q1[1]; now with a more focused portfolio novartis.com ↗
In April, Sandoz received US approval of Glatopa, the first fully substitutable generic version of Teva's Copaxone ® (glatiramer acetate) 20 mg/ml one-time-daily injection for relapsing forms of multiple sclerosis therapy. |
| 2015-04-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C. tevapharm.com ↗
The data show the adjusted mean annualized relapse rate was significantly lower for ES over 36 months (0.23 vs 0.30, risk ratio [RR]=0.770; P=0.0052). |
| 2015-04-16 | Novartis Pharmaceuticals | Regulatory Sandoz receives FDA approval for GlatopaTM as the first generic competitor to MS therapy Copaxone® 20mg novartis.com ↗
Sandoz, a Novartis company, today announced the US approval of Glatopa TM , the first generic version of Teva's Copaxone ® (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy. |
| 2014-12-25 | Takeda | Regulatory Takeda Submits a New Drug Application for Glatiramer Acetate in Japan for the Relapse Prevention of Multiple Sclerosis takeda.com ↗
Takeda Pharmaceutical Company Limited (Takeda) announced today that it has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for glatiramer acetate (active ingredient), for the relapse prevention of multiple sclerosis. |
| 2014-12-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Positive Outcome in Europe for Three-Times-a-Week COPAXONE® (Glatiramer Acetate) 40 mg/ml for the Treatment of Relapsing Forms of Multiple Sclerosis (RMS) tevapharm.com ↗
The outcome follows a Positive Assessment Report from the United Kingdom, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency (MHRA), and all Concerned Member States (CMS) in Europe who were involved in the procedure. |
| 2014-09-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Gene Expression Analysis at Joint Actrims-Ectrims Meeting Demonstrating Copaxone® (Glatiramer Acetate Injection) Has a Complex Profile tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced that new scientific data presented at the MS Boston 2014: Joint ACTRIMS-ECTRIMS Meeting reveals differences in the gene expression profile between COPAXONE® (glatiramer acetate injection) and other glatiramer acetate products. |
| 2014-09-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Data Which Demonstrate Reduction of Injection-Related Adverse Events with the Less Frequent Dosing of Three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg Compared to Daily COPAXONE® 20 mg tevapharm.com ↗
The primary endpoint of the GLACIER study, the adjusted mean annualized rate of injection-related adverse events (IRAEs), was achieved with a 50 percent reduction with the three-times-a-week COPAXONE® 40 mg dosing regimen versus the daily COPAXONE® 20 mg regimen. |
| 2014-05-01 | Biogen | Results New TYSABRI® Analysis at AAN Annual Meeting Shows Improved Walking Speed in Significant Number of MS Patients biogen.com ↗
Additional data from observational registry studies show that switching to TYSABRI after experiencing a multiple sclerosis (MS) relapse while taking interferon beta (IFNβ) or glatiramer acetate (GA) reduced the risk of future relapses and treatment discontinuation. |
| 2014-04-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Shares New Data on MS Therapies at 66th American Academy of Neurology (AAN) Annual Meeting tevapharm.com ↗
Results from the open-label Phase IIIb GLatiramer Acetate low frequenCy safety and patIent ExpeRience (GLACIER) study, comparing the safety and tolerability of new three-times-a-week COPAXONE® 40 mg/mL to daily COPAXONE® 20 mg/mL, were presented during an oral session today by principal investor, Dr. Jerry Wolinsky, Bartels Family and Opal C. Rankin Professor of Neurology at The University of Texas Medical School at Houston. |
| 2014-01-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces U.S. FDA Approval of Three-Times-a-Week COPAXONE® (glatiramer acetate injection) 40mg/mL tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental new drug application (sNDA) for three-times-a-week COPAXONE® 40mg/mL, a new dose of COPAXONE®. |
| 2014-01-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Data Demonstrates Key Genes Respond Differently to COPAXONE® (glatiramer acetate injection) Versus a Purported Generic Glatiramer Acetate tevapharm.com ↗
The study demonstrated a predictable and therapeutically-aligned impact of COPAXONE® on genes associated with key immune response-related cells. |
| 2013-10-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present Further Results of Twenty-Year Open-Label Extension Study of Glatiramer Acetate 20 mg Daily for Relapsing-Remitting Multiple Sclerosis tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced further results from a long-term, open-label extension study of glatiramer acetate (GA). |
| 2013-07-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Phase III Data Published in Annals of Neurology Show That a Higher Concentration Dose of Glatiramer Acetate Given Three Times a Week Reduced Annualized Relapse Rates in the Treatment of Relapsing-Remitting Multiple Sclerosis tevapharm.com ↗
The published data show that glatiramer acetate (GA) 40mg/ 1 mL injections administered three times a week reduced annualized relapse rates by 34.0% (p<0.0001) |
| 2013-05-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Acceptance of sNDA for a Higher Concentration Dose of COPAXONE® Given Three Times a Week tevapharm.com ↗
We are pleased that the FDA has accepted for review our sNDA. |
| 2013-03-18 | Biogen | Results ADDING MULTIMEDIA New TYSABRI Data Reaffirm Substantial Efficacy in Treatment of People with MS and Demonstrate Stability of Anti-JCV Antibody Status biogen.com ↗
TYSABRI demonstrated a significantly lower rate of first relapse compared to interferon beta (IFN) and glatiramer acetate (GA). |
| 2013-03-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Research on CNS Product Portfolio and Pipeline at 2013 American Academy of Neurology Annual Meeting tevapharm.com ↗
data demonstrating that more patients on COPAXONE® (glatiramer acetate) persisted with treatment than those on beta interferon (IFN). |
| 2012-10-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present Positive Data for Glatiramer Acetate 40 mg/1 ml Given Three Times Weekly for Relapsing-Remitting Multiple Sclerosis tevapharm.com ↗
In the GALA study, a one-year randomized, double-blind, placebo controlled study, GA 40 mg/1 ml significantly reduced annualized relapse rates (ARR) by 34.4 percent (p<0.0001) versus placebo. |
| 2012-06-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage for Glatiramer Acetate Given Three Times Weekly for Relapsing-Remitting Multiple Sclerosis tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced positive top-line results from the GALA (Glatiramer Acetate Low-Frequency Administration) Phase III clinical trial assessing the efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate injection (GA) administered subcutaneously three times a week compared to placebo in relapsing-remitting multiple sclerosis (RRMS) patients. |
| 2012-04-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Preliminary Data Suggest Spasticity May Be Reduced in Relapsing-Remitting Multiple Sclerosis Patients Who Transitioned to Teva's COPAXONE® tevapharm.com ↗
Interim results for the first 52 of 110 participants revealed a significant reduction in muscle stiffness, pain and discomfort, as well as the effect of spasticity on the ability to walk, body movements and activities of daily living (ADLs). |
| 2012-04-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces New Data on Central Nervous System Products to Be Presented at 2012 American Academy of Neurology Annual Meeting tevapharm.com ↗
Interim data from a prospective study showing a significant reduction in spasticity in multiple sclerosis patients who switched to COPAXONE(R) after discontinuing interferon-beta treatment |
| 2012-01-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Advanced Magnetic Resonance Imaging Technology Suggests Axonal Repair in Multiple Sclerosis Patients Treated with COPAXONE® tevapharm.com ↗
Researchers utilizing an advanced magnetic resonance imaging (MRI) technology to characterize and chart the evolution of MS lesions found that relapsing-remitting multiple sclerosis (RRMS) patients treated with COPAXONE® (glatiramer acetate injection) experienced significantly increased magnetization transfer ratio (MTR). |
| 2011-10-26 | Biogen | Results Biogen Idec Announces Positive Top-Line Results from Second Phase 3 Trial Investigating Oral BG-12 (Dimethyl Fumarate) in Multiple Sclerosis biogen.com ↗
The CONFIRM study’s reference comparator, glatiramer acetate (GA; 20 mg subcutaneous daily injection), reduced the ARR by 29 percent (p< 0.02) compared with placebo at two years. |
| 2011-10-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Treatment with COPAXONE® in Multiple Sclerosis Demonstrated Remyelination and Neuroprotective Effects in a Preclinical Setting tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced preclinical data demonstrating reparative and neuroprotective effects of treatment with COPAXONE® (glatiramer acetate injection) in experimental autoimmune encephalomyelitis (EAE) models. |
| 2011-10-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Significant Reduced Loss of Brain Volume in Multiple Sclerosis Patients Treated with COPAXONE(R) tevapharm.com ↗
In the study, the COPAXONE(R) treatment arm resulted in a -2.27 percent change in brain volume (PCVB) as compared to baseline versus -2.62 percent for Avonex(R) (low-dose interferon), -3.21 percent for Betaseron(R)/Rebif(R) (high-dose interferon). |
| 2011-04-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Study Demonstrated Significant Reduction in Annualized Relapse Rate and Halting of Disability Progression in MS Patients Switching to Copaxone® tevapharm.com ↗
The global Coptimize study, which followed 688 patients from 19 countries, demonstrated that patients who switched to Copaxone® (glatiramer acetate injection) from other approved disease modifying therapies experienced a significant reduction of 61 percent (p<0.0001; signed rank test) in ARR. |
| 2011-04-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Presentation of New Data on Multiple Sclerosis and Parkinson's Disease Treatments at 2011 American Academy of Neurology Annual Meeting tevapharm.com ↗
Additional data from the QualiCop study demonstrating the effects of Copaxone® treatment on progression of disability, cognition and fatigue and the impact of these factors on compliance and adherence. |
| 2010-12-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory FDA Issues Complete Response Letter for Lower-Volume Glatiramer Acetate sNDA tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for a lower-volume (0.5mL) injection of glatiramer acetate. |
| 2010-10-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Early Initiation of Treatment with Copaxone® Provides Greater Effects in Delaying Conversion to Clinically Definite MS tevapharm.com ↗
Early treatment with Copaxone® reduced the risk of progression to CDMS by 41 percent (p=0.0005) compared with delayed treatment and delayed time to conversion to CDMS by almost three years or 972 days. |
| 2010-06-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Positive Results From a Study Assessing a New Formulation of COPAXONE® tevapharm.com ↗
Patients receiving the lower-volume injection reported significantly less pain immediately following and five minutes after administration (p<0.0001). |
| 2010-02-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Copaxone® 15-Year Study in Multiple Sclerosis Patients Demonstrates Robust Long-Term Efficacy and Safety tevapharm.com ↗
The 15-year clinical study demonstrated that more than 80 percent of patients were still walking without assistance despite a mean MS disease duration of 22 years, and two-thirds of patients have not transitioned to secondary progressive MS. |
| 2009-09-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Copaxone® Significantly Reduced Disease Severity in Long-Term Treated Multiple Sclerosis Patients tevapharm.com ↗
Results demonstrated that 51 percent of long-term COPAXONE® treated patients shifted to lower severity grades (p<0.0001). |
| 2009-04-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Long-Term Study with COPAXONE® Indicated Protective Effect on Brain Tissue in Multiple Sclerosis Patients tevapharm.com ↗
New data presented today provided evidence that long-term treatment with COPAXONE® (glatiramer acetate injection) may offer sustained protection from neuronal/axonal injury. |
| 2009-04-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Data on its Innovative Therapies for Multiple Sclerosis and Parkinson's Disease at the Upcoming 2009 American Academy of Neurology Annual Meeting tevapharm.com ↗
Long-term COPAXONE® (glatiramer acetate injection) data include an analysis demonstrating neuroprotection in relapsing-remitting multiple sclerosis (RRMS) patients. |
| 2009-03-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Response to Citizen Petition tevapharm.com ↗
The FDA declined to review the CP "without comment on the approvability of any Abbreviated New Drug Application (ANDA) or New Drug Application (NDA) for a glatiramer acetate injection drug product because it would be premature and inappropriate to do so at this time." |
| 2009-03-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Copaxone® Approved by the FDA for Patients with a First Clinical Event Suggestive of Multiple Sclerosis tevapharm.com ↗ |
| 2009-02-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Copaxone® is Approved for Treatment of Patients with a First Clinical Event Suggestive of Multiple Sclerosis tevapharm.com ↗
Approval of an expanded label for COPAXONE® to include the treatment of CIS patients was also provided by the Australian Health Authority |
| 2008-09-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Copaxone® Demonstrated Protective Effect in Patients with Clinically Isolated Syndrome Suggestive of Multiple Sclerosis tevapharm.com ↗
The data represent the first evidence of neuro-axonal protection by a disease modifying therapy in patients presenting with a first clinical event suggestive of MS. |
| 2008-09-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Longest Prospective Study in MS Confirmed Robust Clinical Benefits and Safety of Copaxone® tevapharm.com ↗
Findings demonstrated that more than 80 percent of patients were able to walk unassisted following 15 years of treatment and average disease duration of 22 years. |
| 2008-09-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Treatment Data at World Congress for Multiple Sclerosis tevapharm.com ↗
Glatiramer Acetate Reduces Multiple Sclerosis Severity: Analysis of Patients from the US Pivotal Studies Using the Multiple Sclerosis Severity Scale |
| 2008-07-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Comments on Paragraph IV Filing for COPAXONE®; Intends to File Lawsuit against Generic Filer for Patent Infringement tevapharm.com ↗ |
| 2008-07-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Provides Update on FORTE Trial tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced top-line results from a Phase III study designed to assess the efficacy, safety and tolerability of glatiramer acetate (GA) 40mg as compared to the approved COPAXONE® 20mg in the treatment of relapsing-remitting multiple sclerosis (RRMS). |
| 2008-04-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Early Treatment With Copaxone® Significantly Delayed Progression To Clinically Definite Multiple Sclerosis tevapharm.com ↗
The PreCISe study results clearly demonstrate that early treatment with COPAXONE®, as early as CIS, reduces the risk of developing MS |
| 2008-04-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Copaxone® Significantly Reduced Annual Relapse Rates And Stabilized Disease Progression In Relapsing Remitting Multiple Sclerosis Patients Failing Interferon Treatment tevapharm.com ↗
The results demonstrated that patients who switched from interferon β (IFNβ) to COPAXONE® (glatiramer acetate injection) experienced a 77 percent reduction in annualized relapse rates (0.63 to 0.14). |
| 2008-03-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Provides Update On Glatiramer Acetate 40mg For Amyotrophic Lateral Sclerosis (ALS) tevapharm.com ↗
Results show that GA 40mg was safe and well-tolerated in ALS patients; however, the study's primary and secondary endpoints were not met. |
| 2007-12-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Early Treatment with COPAXONE® Demonstrated Robust Protection against Progression to Clinically Definite Multiple Sclerosis in the PreCISe Study tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced the positive results from a pre planned interim analysis of the PreCISe trial in patients presenting with a first clinical event and MRI features suggestive of multiple sclerosis (MS). |
| 2007-10-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Copaxone® Significantly Decreases Disease Activity In Patients Who Switched From Interferon Beta (Ifnb) Due To Development Of Neutralizing Antibodies (Nabs) tevapharm.com ↗
Patients treated with interferon beta (IFNb) who have experienced loss of efficacy due to the development of neutralizing antibodies, had a significant delay in time to first relapse (p=0.0389) following switch to COPAXONE®. |
| 2007-10-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Long-Term Study Shows Copaxone® Significantly Slows Progression Of Disability And Reduces Relapse Rates In Patients With Relapsing-Remitting Multiple Sclerosis tevapharm.com ↗
The study demonstrates significant clinical benefits on both disability and relapse rates in patients continuously treated with COPAXONE® (glatiramer acetate injection) for an average of 8 years. |
| 2007-06-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Copaxone® Pre-Filled Syringe Can Now Be Stored For Up To One Month At Room Temperature tevapharm.com ↗
With this supplemental amendment, COPAXONE® may now be stored by patients at room temperature for up to one month. |
| 2007-04-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Data Published In Neurology Showed That Higher Dose Of Copaxone® Increased Efficacy In Relapsing-Remitting Multiple Sclerosis (Rrms) tevapharm.com ↗
A 9-month, randomized, double-blind, parallel-group Phase II study of 90 patients comparing a 40 mg dose of COPAXONE® given daily to the currently approved COPAXONE® 20 mg dose showed a 38 percent greater reduction in inflammatory disease activity as measured by magnetic resonance images (MRI) of the brain. |
| 2006-09-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Confirmed Antibodies to Copaxone® Do Not Impact Its Established and Sustained Long-Term Efficacy in Multiple Sclerosis tevapharm.com ↗ |
| 2006-04-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces that Higher Dose of Copaxone® Showed Increased Efficacy in Multiple Sclerosis (Ms) tevapharm.com ↗
A new, higher dose of Copaxone® (glatiramer acetate injection) shows promising results in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). |
| 2002-11-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Potential Neuroprotection Properties of Copaxone® discovered by Researchers tevapharm.com ↗
According to a study published in the November 2002 issue of Brain, COPAXONE® stimulates T-cells to produce the neuroprotection factor BDNF (brain-derived neurotrophic factor) in tissue culture using T-cells from a COPAXONE® patient. |
| 2002-11-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Terminate the Promise Trial Following Unfavorable Interim Analysis tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: Teva) announced that an interim analysis of its clinical trial on primary progressive multiple sclerosis showed that it was improbable that the study at its current protocol, would reach statistical significance. |
| 2002-10-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces That Early Treatment of MS with Copaxone® delays Accumulation of Additional Brain Lesions tevapharm.com ↗
The delay of starting therapy resulted in six new enhancing lesions per patient during the first nine study months that could have been prevented, according to the study. |
| 2002-10-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Copaxone® Approved for Seven Days Room Temperature Storage in 16 European Countries tevapharm.com ↗
Teva Pharmaceutical Industries, Ltd., (NASDSQ: TEVA) and Aventis (NYSE: AVE), announced that the application for seven days room temperature storage of Copaxone® (glatiramer acetate) has been approved across sixteen European countries. |
| 2002-05-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Copaxone® Now Available in Canada in a Pre-Filled, Ready-To-Use-Syringe tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced that the COPAXONE® (glatiramer acetate injection) Pre-Filled Syringe (PFS) has received a Notice of Compliance from Health Canada and is now available. |
| 2001-10-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces that Health Canada Has Approved Enhanced Labeling for Copaxone® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that Health Canada has approved enhanced labeling for its multiple sclerosis drug COPAXONE® (glatiramer acetate for injection). |
| 2001-10-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva's Copaxone® Shown to Reduce "Black Holes" in the Brain tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that a study published in the August issue of Neurology showed that COPAXONE® (glatiramer acetate for injection) reduced by 50% the percentage of permanent "black holes" that developed in patients with relapsing-remitting multiple sclerosis. |
| 2001-09-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Pharmaceutical Industries Announce Interim Results of Coral Study tevapharm.com ↗
We have been very surprised by the relatively few number of relapses during the trial compared to the same patients' relapse rates in the prior year. |
| 2001-08-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory 15 European Countries Agree to Approve Copaxone® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and Aventis Pharma AG, the pharmaceutical company of Aventis (NYSE: AVE) announced today that 15 European countries agreed to approve Copaxone® (glatiramer acetate) for the reduction in frequency of relapses in patients with relapsing-remitting multiple sclerosis. |
| 2000-08-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Received Marketing Approval for Copaxone® in the U.K. tevapharm.com ↗
Teva Pharmaceutical Industries, Ltd., (Nasdaq: TEVA) announced today that Copaxone® was approved for marketing in the U.K. |
| 2000-06-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Pharmaceutical Industries Ltd. Announces Copaxone® Recommended for Approval in the U.K. a Major Step Towards the Approval in the E.U. tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that Copaxone® (glatiramer acetate for injection) has been recommended for approval for the treatment of relapsing-remitting multiple sclerosis (RR MS) by the Licensing Authority in the U.K. |
| 1999-05-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Pharmaceutical Industries Ltd. receives approval from the swiss intercantonal medicines control office (iks) for sale of copaxoneÒ in switzerland tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVIY) announced today at its investor seminar and field trip in Hungary that the Swiss Intercantonal Medicines Control office, the IKS, has granted marketing clearance for CopaxoneÒ for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). |
| 1999-02-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Pharmaceutical Industries Ltd. Reports 1998 Year End and Fourth Quarter Financial Results tevapharm.com ↗
A double blind MRI clinical trial was completed during the fourth quarter of 1998 showing significant positive results. |
All press releases naming this drug 165 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 165 releases opens the full record — a long page | ||
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glatiramer acetate | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗59“Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to...” NCT01874145 ↗ “Standard-of-care on first-line treatment such as interferon-beta, glatiramer acetate, teriflunomide, dimethylfumarate, ponesimod and ozanimod.” NCT06715605 ↗ “Discontinuation of patients' own disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide)” NCT04260711 ↗ “Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.” NCT00097760 ↗ “selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.” NCT01216072 ↗ “DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC” NCT04792567 ↗ “Interferon-β (IFN-β), glatiramer acetate, dimethyl fumarate, teriflunomide or diroximel fumarate” NCT06663189 ↗ “Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot)” NCT02212886 ↗ “Glatiramer acetate minimum dose 20mg or maximum dose 40mg twice a day or three times a week” NCT04788615 ↗ “Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)” NCT03362294 ↗ |
| Known as | COP-1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201507 ↗ |
| Known as | Copaxone | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗19“The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis.” NCT00326625 ↗ “Copaxone is known for its high safety profile and for acting as an effective immunomodulatory agent for the treatment of MS.” NCT00731172 ↗ “Investigational Product:Glatiramer Acetate (Copaxone® , Teva Pharmaceutical Industries Ltd.)” NCT02023424 ↗ “Treatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate)” NCT00039988 ↗ “glatiramer acetate (GA, i.e., Copaxone®) injection” NCT02212886 ↗ “Glatiramer Acetate (Copaxone®)” NCT01489254 ↗ “glatiramer acetate (Copaxone)” NCT01623596 ↗ |
| Known as | Copaxone (glatiramer acetate) | “Copaxone (glatiramer acetate)” NCT03535298 ↗ |
| Known as | Copaxone (Glatiramer acetate, COP, Copolymer-1) | “Copaxone (Glatiramer acetate, COP, Copolymer-1)” NCT00677664 ↗ |
| Known as | copolymer 1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00004814 ↗ |
| Known as | GA Depot | “Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)” NCT03362294 ↗ |
| Known as | Glatopa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201507 ↗ |
| Known as | Glatopa (glatiramer acetate) | “Glatopa (glatiramer acetate)” NCT03535298 ↗ |
| Known as | GTR | “Glatiramer Acetate (GTR)” NCT01489254 ↗ |
| Modality | Peptide | “copolymer 1, a mixture of synthetic polypeptides” NCT00004814 ↗ |
| Modality | Small molecule | — CHEMBL1201507 ↗ |
| Route | Subcutaneous | “subcutaneously each day” NCT00004814 ↗ |