Drugs / dimethyl fumarate
dimethyl fumarate
also known as
BG00012 · DMF · Tecfidera. · BG-12 · DR-DMF · LAS41008 · Tecfidera (dimethyl fumarate)
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed multiple sclerosis 3 milestones | |||||
| Filed | US (FDA) | — | multiple sclerosis | 2017-06-12 | “FDA has accepted for review its Paragraph IV Abbreviated New Drug Application (ANDA) filing for Dimethyl Fumarate” upsher-smith.com ↗ |
| Filed | Other | — | multiple sclerosis | — | “In addition to earlier filings in the U.S. and EU, Biogen Idec filed in Canada, Switzerland and Australia in the second quarter for regulatory approval for BG-12 (dimethyl...” biogen.com ↗ |
| Filed | EU (EMA) | — | multiple sclerosis | — | “Biogen Idec also submitted a Marketing Authorisation Application to the European Medicines Agency for marketing approval of BG-12 in March 2012.” biogen.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | TECFIDERA | — | 2014-12-03 – 2023-02-10 | fda.gov ↗ |
| Approved | EU (EMA) | Tecfidera | — | 2014-01-30 | europa.eu ↗ |
| Approved | US (FDA) | TECFIDERA | — | 2013-03-27 | fda.gov ↗ |
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 1 missed | ||||||
| Phase 1 | NCT02955693 | Sep → Oct 2016 | psoriasis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02784834 | Jun 2016 → Feb 2019 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Michael Choi | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02337426 | Feb 2015 → Nov 2016 | adult glioblastoma, giant cell glioblastoma, gliosarcoma | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1 | NCT01924832 | Aug 2013 → Apr 2014 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01915901 | Aug → Dec 2013 | — | Biogen | Completed | Missed primary |
| Phase 1 | NCT01453426 | Jan → Apr 2012 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01281111 | Feb → Mar 2011 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT00837785 | Feb → Oct 2009 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04890366 | Dec 2021 → Dec 2022 | ischemic stroke | Xuanwu Hospital, Beijing | Unknown | No outcome recorded |
| Phase 1/2 | NCT04890353 | Dec 2021 → Feb 2023 | ischemic stroke | Xuanwu Hospital, Beijing | Terminated | No outcome recorded |
| Phase 29 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT06850597 | Oct 2024 → Dec 2027 expected | Alzheimer disease | Medical University of Lodz | Recruiting | No outcome recorded |
| Phase 2 | NCT04292080 | Feb 2022 → Apr 2027 expected | dry age related macular degeneration | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT04891497 | Jun → Dec 2021 | ischemic stroke | Xuanwu Hospital, Beijing | Withdrawn | No outcome recorded |
| Phase 2 | NCT04890379 | Jun → Dec 2021 | intracerebral hemorrhage | Xuanwu Hospital, Beijing | Withdrawn | No outcome recorded |
| Phase 2 | NCT02410200 | Sep 2015 → Sep 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 2 | NCT02546440 | Sep 2015 → Sep 2021 | primary cutaneous T-cell lymphoma | University Medical Center Mannheim | Completed | No outcome recorded |
| Phase 2 | NCT02097849 | Feb 2015 → May 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | Missed primary |
| Phase 2 | NCT01156311 | Jun 2010 → Mar 2012 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00168701 | Oct 2004 → Mar 2006 | multiple sclerosis | Biogen | Completed | Met primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07548996 | Apr 2026 → Dec 2028 expected | type 1 diabetes mellitus | Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06513533 | Apr 2024 → Mar 2028 expected | adrenomyeloneuropathy | Pujol, Aurora, M.D. | Active not recruiting | No outcome recorded |
| Phase 317 trials · 3 met primary | ||||||
| Phase 3 | NCT07483632 | Nov 2026 → Jul 2034 expected | multiple sclerosis | Biogen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07189325 | Jun 2026 → Jun 2031 expected | relapsing-remitting multiple sclerosis | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 3 | NCT07258394 | Jan 2026 → Dec 2028 expected | type 1 diabetes mellitus | Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT03870763 | Mar 2019 → Jul 2022 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT02428218 | May 2016 → Jan 2027 | relapsing-remitting multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
| Phase 3 | NCT02555215 | Feb 2016 → Sep 2018 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT02525874 | Aug 2015 → Apr 2017 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT02430532 | May 2015 → Jan 2016 | secondary progressive multiple sclerosis | Biogen | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02428231 | Apr → Dec 2015 | multiple sclerosis | Biogen | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02283853 | Aug 2014 → Jul 2025 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT02579681 | Apr 2014 → Dec 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01838668 | Mar 2013 → Jun 2015 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 3 | NCT01726933 | Nov 2012 → Oct 2014 | psoriasis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01568112 | Apr → Oct 2012 | — | Biogen | Completed | Mixed |
| Phase 3 | NCT00835770 | Feb 2009 → Nov 2019 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00451451 | Jun 2007 → Aug 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 3 | NCT00420212 | Jan 2007 → Feb 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 415 trials · 1 missed | ||||||
| Phase 4 | NCT07138833 | Sep 2025 → Apr 2028 expected | multiple sclerosis | Qilu Pharmaceutical (Hainan) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05959759 | Jul → Dec 2023 | brain aneurysm | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05658484 | Jun 2023 → Mar 2025 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT04263610 | Sep 2019 → Feb 2022 | psoriasis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02901106 | May → Oct 2017 | relapsing-remitting multiple sclerosis | Fondation Ophtalmologique Adolphe de Rothschild | Terminated | No outcome recorded |
| Phase 4 | NCT02675413 | Apr 2016 | relapsing-remitting multiple sclerosis | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase 4 | NCT02471560 | Nov 2015 → Jun 2017 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT02683863 | Aug 2015 → Jan 2017 | multiple sclerosis | Multiple Sclerosis Center of Northeastern New York | Completed | No outcome recorded |
| Phase 4 | NCT02472938 | Jul 2015 → Jul 2019 | relapsing-remitting multiple sclerosis | Biogen | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT02090348 | Jun 2015 → Oct 2017 | relapsing-remitting multiple sclerosis | Biogen | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT02125604 | Jun 2014 → Feb 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT02090413 | May 2014 → Feb 2015 | relapsing-remitting multiple sclerosis | Biogen | Completed | Missed primary |
| Phase 4 | NCT01930708 | Oct 2013 → Mar 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT01088165 | May 2010 → May 2013 | cardiovascular disorder, psoriasis, type 2 diabetes mellitus | Medical University of Vienna | Unknown | No outcome recorded |
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT04260711 | Jul 2020 → Aug 2023 | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Amsterdam UMC, location VUmc | Unknown | Missed primary |
| Comparator or background therapy26 trials | ||||||
| Phase 1 | NCT04022473 Comparator | Jul → Oct 2019 | multiple sclerosis | Banner Life Sciences LLC | Completed | No outcome recorded |
| Phase 1 | NCT04570670 Comparator | Jan → Feb 2017 | relapsing-remitting multiple sclerosis | Banner Life Sciences LLC | Completed | Met primary |
| Phase 1 | NCT02981082 Comparator | Dec 2016 → Feb 2020 | pulmonary hypertension, systemic sclerosis | Robert Lafyatis | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02201849 Comparator | Jul → Dec 2014 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01069913 Comparator | Oct 2009 | — | Biogen | Completed | No outcome recorded |
| Phase 1/2 | NCT05417269 Comparator | Apr 2022 → May 2025 | relapsing-remitting multiple sclerosis | Imcyse SA | Unknown | No outcome recorded |
| Phase 2 | NCT06715605 Comparator | Apr 2025 | multiple sclerosis | University Hospital, Antwerp | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02975349 Comparator | Mar 2017 → Jan 2018 | relapsing-remitting multiple sclerosis | EMD Serono Research & Development Institute, Inc. | Terminated | Met primary |
| Phase 2 | NCT02959658 Comparator | Dec 2016 → Dec 2019 | primary progressive multiple sclerosis | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 2 | NCT02438137 Comparator | May 2015 → Apr 2016 | obstructive sleep apnea syndrome | University of Michigan | Completed | No outcome recorded |
| Phase 2 | NCT00810836 Comparator | Dec 2008 → Feb 2010 | rheumatoid arthritis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00273364 Comparator | Nov 2005 → Jan 2017 | multiple sclerosis | Northwestern University | 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 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
| Phase 3 | NCT03093324 Comparator | Mar 2017 → Jun 2019 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 3 | NCT01815723 Comparator | Jun 2016 → Jun 2017 | psoriasis | Forward-Pharma GmbH | Withdrawn | No outcome recorded |
| Phase 3 | NCT02746744 Comparator | May 2016 → Jul 2021 | relapsing-remitting multiple sclerosis | Anders Svenningsson | Completed | Met primary |
| Phase 4 | NCT04792567 Comparator | Apr → Sep 2021 | secondary progressive multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT03331835 Comparator | Nov 2017 → Jan 2019 | psoriasis | LEO Pharma | Completed | Met primary |
| Phase 4 | NCT03345940 Comparator | Apr 2017 → Oct 2019 | relapsing-remitting multiple sclerosis | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02739542 Comparator | Mar 2016 → Mar 2021 | multiple sclerosis | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02461069 Comparator | May 2015 → Jan 2018 | relapsing-remitting multiple sclerosis | University Hospital Muenster | Completed | No outcome recorded |
| Phase 4 | NCT02410278 Background | Mar 2015 → Feb 2017 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT02343159 Background | Feb 2015 → Apr 2016 | multiple sclerosis | Biogen | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03092544 Comparator | Feb 2015 → Dec 2018 | multiple sclerosis | Multiple Sclerosis Center of Northeastern New York | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 50
| Date | Issuer | Release |
|---|---|---|
| 2023-12-19 | Biogen | Regulatory Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of Biogen’s product TECFIDERA® (dimethyl fumarate) held by Accord, Mylan, Neuraxpharm, Polpharma and Teva. |
| 2023-05-03 | Biogen | Regulatory Biogen Files Form 8-K biogen.com ↗
On May 3, 2023, the European Commission notified Biogen Inc. of its decision that the period of regulatory market protection for Tecfidera extends until February 2, 2025.” |
| 2023-03-16 | Biogen | Regulatory Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection biogen.com ↗
With this favorable decision, Biogen believes that TECFIDERA is entitled to regulatory marketing protection in the European Union until at least February 4, 2024. |
| 2021-10-13 | Biogen | Results New Data at ECTRIMS 2021 Highlight Biogen’s Focus on Patient-Centered Outcomes and Improving the MS Patient Experience biogen.com ↗
In the Phase 3 EVOLVE-MS-2 study, VUMERITY (n=253) demonstrated that an improved GI tolerability profile compared to TECFIDERA ® (dimethyl fumarate) (n=251) may simplify initiation of therapy. |
| 2021-04-15 | Biogen | Regulatory Biogen Grows Presence in China with the Approval of TECFIDERA® (dimethyl fumarate) for the Treatment of Relapsing Multiple Sclerosis biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) today announced that China’s National Medical Products Administration (NMPA) has approved TECFIDERA ® (dimethyl fumarate) for the treatment of relapsing multiple sclerosis (MS). |
| 2020-10-07 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark receives ANDA approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg , the generic version of Tecfidera1 Delayed-Release Capsules, 120 mg and 240 mg, of Biogen, Inc. |
| 2020-10-06 | Lupin Limited | Regulatory Lupin Receives Approval for Dimethyl Fumarate Delayed-Release Capsules lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Tecfidera® Delayed-Release Capsules, 120 mg and 240 mg, of Biogen, Inc. |
| 2020-09-25 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives final approval for Dimethyl Fumarate Delayed Release Capsules zyduslife.com ↗ |
| 2020-09-11 | Biogen | Results New Data at ACTRIMS-ECTRIMS Meeting Showcase Safety and Efficacy of Biogen’s Industry-Leading MS Portfolio biogen.com ↗
Findings from the five-week EVOLVE-MS-2 study reinforce clinically meaningful improvements in patient-assessed gastrointestinal (GI) tolerability associated with VUMERITY treatment (n=253) compared to TECFIDERA ® (dimethyl fumarate) (n=251), and support its impact on quality of life for people with relapsing MS. |
| 2020-05-19 | Biogen | Results New Data at AAN Showcase Biogen’s Commitment to Advancing Innovation in MS biogen.com ↗
Patients treated with VUMERITY ® (diroximel fumarate) and TECFIDERA ® (dimethyl fumarate) showed a significant reduction of gadolinium-enhancing lesions compared to baseline |
| 2019-11-22 | Biogen | Results Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With VUMERITY™ (diroximel fumarate) Compared to TECFIDERA® (dimethyl fumarate) biogen.com ↗
Results for the primary endpoint show patients treated with VUMERITY self-reported 46 percent fewer days with intensity scores of ≥2 on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS), compared to TECFIDERA (adjusted rate ratio [95% confidence interval]: 0.54 [0.39−0.75], p = 0.0003). |
| 2019-10-09 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives tentative ANDA approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dimethyl Fumarate Delayed -Release Capsules, 120 mg and 240 mg, a generic version of Tecfidera®1 Capsules, 120 mg and 240 mg, of Biogen Inc. |
| 2019-09-11 | Biogen | Results New Data Presented at ECTRIMS Reinforce Long-term Benefits of TECFIDERA® (dimethyl fumarate) Over 10 Years biogen.com ↗
The well-characterized safety profile of TECFIDERA was consistent over 10 years, with no increased occurrence of serious infections. |
| 2019-07-30 | Biogen | Results Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis biogen.com ↗
The overall proportion of patients with AEs leading to study discontinuation were 1.6% for diroximel fumarate and 6.0% for dimethyl fumarate. |
| 2019-07-30 | Alkermes, Inc. | Results Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis alkermes.com ↗
Diroximel fumarate was statistically superior to dimethyl fumarate on the study's pre-specified primary endpoint |
| 2019-05-07 | Biogen | Results Data at AAN Demonstrate Biogen’s Leadership and Commitment to Innovation in MS biogen.com ↗
Pooled Phase 3 data reinforce efficacy profile of TECFIDERA ® (dimethyl fumarate) |
| 2019-05-01 | Biogen | Results Biogen To Present Data At AAN Highlighting Its Innovative Marketed Treatments And Investigational Pipeline Programs For Complex Neurodegenerative Diseases biogen.com ↗
Dimethyl Fumarate Exerts Selective Effects on Key B Cell Subsets and IgG Levels Which May Contribute to Its Therapeutic Benefit in MS While Maintaining Protective Humoral Immunity |
| 2018-12-19 | Lupin Limited | Regulatory Lupin receives tentative US FDA approval for Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mgn lupin.com ↗ |
| 2018-11-22 | Zydus Lifesciences Limited | Regulatory Zydus receives approvals from the USFDA for Atorvastatin Calcium Tablets and Dimethyl Fumarate Delayed-Release Capsules zyduslife.com ↗
The group also received a tentative approval for Dimethyl Fumarate Delayed -Release Capsules, 120 mg and 240 mg (US RLD – TECFIDERA® capsules). |
| 2018-10-11 | Biogen | Results Biogen Advances Research to Improve Outcomes for Patients With Multiple Sclerosis biogen.com ↗
Real-world data add to the large body of evidence establishing the long-term effectiveness of TECFIDERA and TYSABRI, including in newly diagnosed patients |
| 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 ↗
including data supporting the use of TECFIDERA ® (dimethyl fumarate) and TYSABRI ® (natalizumab) early within the disease course. |
| 2017-06-12 | Upsher-Smith Laboratories | Regulatory Sawai Pharmaceutical Announces Paragraph IV ANDA Filing for Dimethyl Fumarate Delayed-Release Capsules upsher-smith.com ↗
the United States Food and Drug Administration (FDA) has accepted for review its Paragraph IV Abbreviated New Drug Application (ANDA) filing for Dimethyl Fumarate Delayed-Release Capsules |
| 2017-04-18 | Biogen | Results Biogen Highlights Advances from Its Neurology Research Programs and Portfolio of Innovative Medicines at AAN Congress biogen.com ↗
TECFIDERA ® and TYSABRI ® Data Support Early Treatment to Improve MS Patient Outcomes |
| 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 ↗
The findings presented at ECTRIMS confirm the results we observed in the TECFIDERA clinical trial program, further supporting its early use to improve outcomes for people living with MS. |
| 2016-09-08 | Biogen | Results Biogen Demonstrates Commitment to Improving Patient Outcomes with Study on Burden of MS and New Clinical Data from Its Leading MS Portfolio biogen.com ↗
Real-world data and new clinical evidence that demonstrate TECFIDERA consistently delivers strong, sustained efficacy in reducing disease activity among newly diagnosed and previously treated patients with relapsing-remitting multiple sclerosis (RRMS). |
| 2016-04-18 | Biogen | Results TECFIDERA® Data Confirm Strong and Sustained Efficacy in Newly Diagnosed MS Patients and Real-World Effectiveness biogen.com ↗
Data from a post-hoc analysis show that more than half of newly diagnosed patients treated with TECFIDERA were free from relapses and disability progression for six years, reinforcing that early, effective treatment with TECFIDERA improves long-term clinical outcomes. |
| 2016-04-12 | Biogen | Results Biogen Data at 2016 AAN Annual Meeting Highlight Its Expansive Portfolio of MS Therapies That Meets Diverse Needs of Patients biogen.com ↗
TECFIDERA data will showcase its strong and sustained efficacy in newly diagnosed MS patients, reinforcing that earlier treatment with TECFIDERA is critical to improve long-term clinical outcomes. |
| 2015-10-07 | Biogen | Results New Data Show Strong, Sustained Effects of TECFIDERA® (Dimethyl Fumarate) in Newly-Diagnosed and Early Disease Course Multiple Sclerosis Patients biogen.com ↗
The data show that TECFIDERA significantly reduced multiple sclerosis (MS) relapses and delayed disability progression in patients who are newly diagnosed and those early in their disease course; these effects were sustained over six years of follow-up. |
| 2015-10-01 | Biogen | Results Biogen to Highlight Broad Research Commitment to MS Care at ECTRIMS Congress, Including New TECFIDERA® Data Demonstrating Importance of Early Treatment biogen.com ↗
TECFIDERA data will demonstrate its strong and sustained efficacy in relapsing-remitting multiple sclerosis (RRMS) among patients who were early in the course of their disease or newly diagnosed. |
| 2015-04-20 | Biogen | Results TECFIDERA® (Dimethyl Fumarate) Data Reinforce Strong, Sustained Efficacy for Newly-Diagnosed MS Patients biogen.com ↗
Data show TECFIDERA significantly reduced relapses and disability progression in newly-diagnosed relapsing-remitting MS (RRMS) patients who had highly active disease. |
| 2015-04-07 | Biogen | Results Biogen Data at AAN Annual Meeting Underscore Commitment to Advancing Patient Care in Neurology biogen.com ↗
TECFIDERA ® (dimethyl fumarate) Data Demonstrate Strong and Sustained Efficacy Across Broad Range of MS Patients |
| 2014-09-11 | Biogen | Results New Data from ENDORSE Show Positive Results Continued over Five Years with TECFIDERA® (Dimethyl Fumarate) in a Wide Range of Multiple Sclerosis Patients biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced that five-year results from the ENDORSE Phase 3 extension study show TECFIDERA ® (dimethyl fumarate) provides strong and sustained efficacy in a broad range of people living with relapsing-remitting multiple sclerosis (RRMS). |
| 2014-04-30 | Biogen | Results New Data Reinforce Efficacy of TECFIDERA® (Dimethyl Fumarate) in MS Patients with High Disease Activity biogen.com ↗
A new post-hoc analysis from the Phase 3 studies, DEFINE and CONFIRM, reinforce that TECFIDERA can be effective in RRMS patients with high disease activity. |
| 2014-02-03 | Biogen | Regulatory TECFIDERA® (Dimethyl Fumarate) Approved in the European Union as a First-Line Oral Treatment for Multiple Sclerosis biogen.com ↗
TECFIDERA ® (dimethyl fumarate) has been approved by the European Commission (EC) as a first-line oral treatment for people with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). |
| 2013-11-22 | Biogen | Regulatory CHMP Determines Dimethyl Fumarate in TECFIDERA® to be a New Active Substance in the European Union biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has determined that dimethyl fumarate in TECFIDERA qualifies as a new active substance (NAS). |
| 2013-10-04 | Biogen | Results New TECFIDERA® (Dimethyl Fumarate) Data Show Sustained Efficacy and Long-Term Safety in a Broad Range of Multiple Sclerosis Patients biogen.com ↗
Interim analyses from the ENDORSE long-term extension study show that TECFIDERA maintained its effect in reducing disease activity in patients treated for four years. |
| 2013-03-22 | Biogen | Regulatory CHMP Issues Positive Opinion for TECFIDERA™ (Dimethyl Fumarate) as a First-Line Treatment for Multiple Sclerosis in the European Union biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) recommending a marketing authorization be granted for TECFIDERA ™ (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). |
| 2012-10-18 | Biogen | Regulatory Biogen Idec Receives Notification of PDUFA Date Extension biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the New Drug Application (NDA) for the marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). |
| 2012-10-12 | Biogen | Results New Data from Phase 3 Studies Provide Additional Evidence Supporting Treatment Effect for Oral BG-12 (Dimethyl Fumarate) in Multiple Sclerosis biogen.com ↗
Analyses of the pooled clinical efficacy results of DEFINE and CONFIRM show that treatment with dimethyl fumarate led to significant reductions in MS relapses and disease progression. |
| 2012-09-19 | Biogen | Results The New England Journal of Medicine Publishes Pivotal Data Demonstrating Efficacy and Safety of Oral BG-12 (Dimethyl Fumarate) in Multiple Sclerosis biogen.com ↗ |
| 2012-05-09 | Biogen | Regulatory US and EU Regulatory Authorities Accept Oral BG-12 Marketing Applications for Review biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the company’s marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS). |
| 2012-04-24 | Biogen | Results Positive Results from Phase 3 CONFIRM Clinical Trial Show Efficacy and Safety of Oral BG-12 in Multiple Sclerosis biogen.com ↗
In CONFIRM, BG-12 demonstrated efficacy across a variety of clinical and radiological outcome measures, as well as favorable safety and tolerability profiles. |
| 2012-02-28 | Biogen | Regulatory Biogen Idec Submits Application to FDA for Approval of Oral BG-12 to Treat Multiple Sclerosis biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). |
| 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 ↗
BG-12 met the CONFIRM study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 44 percent for BID (p< 0.0001) and by 51 percent for TID (p< 0.0001) versus placebo at two years. |
| 2011-10-21 | Biogen | Results Oral BG-12 (Dimethyl Fumarate) Significantly Reduced Multiple Sclerosis (MS) Relapses and Disability Progression in Define Phase 3 Clinical Trial biogen.com ↗
Results showed that 240 mg of BG-12, administered either twice a day (BID) or three times a day (TID), significantly reduced the proportion of patients who relapsed by 49 percent and 50 percent, respectively, at two years compared with placebo. |
| 2011-04-11 | Biogen | Results Biogen Idec Announces Positive Top-Line Results from the First Phase 3 Trial Investigating Oral BG-12 (DIMETHYL FUMARATE) in Multiple Sclerosis biogen.com ↗
Results showed that 240 mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a highly statistically significant reduction (p<0.0001) in the proportion of patients with RRMS who relapsed at two years compared with placebo. |
| 2010-04-05 | Biogen | Results Biogen Idec Strengthens Position as a Leader in Neurology with 38 Data Presentations at 62nd Annual Meeting of the American Academy of Neurology biogen.com ↗ |
| 2009-09-02 | Biogen | Results Biogen Idec Showcases More Than 70 Data Presentations at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis biogen.com ↗
Dimethyl fumarate (BG00012) inhibits astrocyte and microglial activation (poster P457), which provides evidence that the compound may have a dual mechanism of action thought to demonstrate anti-inflammatory and neuroprotective properties; |
| 2008-10-23 | Biogen | Results Phase IIb Data Published in the Lancet Show That BG-12, Biogen Idec's Novel Oral Compound, Significantly Reduced Brain Lesions in Patients with Multiple Sclerosis biogen.com ↗
The data also showed a 53 percent reduction in the mean number of T1-hypointense lesions and a 44 percent reduction in cumulative new Gd+ lesions in patients treated with BG-12 compared to treatment with placebo. |
| 2008-09-18 | Biogen | Regulatory Biogen Idec Features Data on AVONEX(R) and TYSABRI(R) and Showcases the Company's Multiple Sclerosis Development Pipeline at the World Congress On Treatment and Research in Multiple Sclerosis biogen.com ↗
Biogen Idec also announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BG-12. |
All press releases naming this drug 57 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 87 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dimethyl-fumarate | “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 ↗68“Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt)” NCT03331835 ↗ “Week 2: FAE forte (DIMETHYL FUMARATE 120mg ETHYL, FUMARATE CALCIUM 87mg, ETHYL FUMARATE ZINC 3mg, ETHYL FUMARATE MAGNESIUM 5mg)starting with 0-0-1 capsule daily” NCT01088165 ↗ “TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.” NCT02901106 ↗ “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 ↗ “BG-12 (dimethyl fumarate) is an oral agent approved in the United States for the treatment of relapsing forms of MS.” PMID 24131282 ↗ Oct 2013 “DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC” NCT04792567 ↗ “Interferon-β (IFN-β), glatiramer acetate, dimethyl fumarate, teriflunomide or diroximel fumarate” NCT06663189 ↗ “Dimethyl fumarate minimum dose of 120mg or maximum dose of 240mg twice a day” NCT04788615 ↗ “MMF (metabolite of dimethyl fumarate [DMF])” NCT02955693 ↗ |
| Known as | BG-12 | “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 ↗1“BG-12 (dimethyl fumarate) is an oral agent approved in the United States for the treatment of relapsing forms of MS.” PMID 24131282 ↗ Oct 2013 |
| Known as | BG00012 | “BG00012 (DMF) (Tecfidera®.)” NCT02683863 ↗9“Dimethyl Fumarate (BG00012)” NCT01281111 ↗ |
| Known as | DMF | “INTRODUCTION: Diroximel fumarate (DRF) and dimethyl fumarate (DMF) are orally administered fumarate disease-modifying therapies (DMTs) for multiple sclerosis (MS).” PMID 38878121 ↗ Jun 20249“Dimethyl fumarate (DMF) acts as an anti-inflammatory agent by activating nuclear factor erythroid 2-related factor 2 (Nrf2) and other pathways.” NCT05959759 ↗ “In a preclinical study we showed the potential of dimethyl fumarate (DMF) to block NF-κB and, specifically, kill CTCL cells.” PMID 37217183 ↗ Aug 2023 “Tecfidera® (dimethyl fumarate [DMF]) is an approved product for the treatment of relapsing forms of multiple sclerosis.” PMID 33797063 ↗ Mar 2021 “Limited data exist for dimethyl fumarate (DMF) treatment in pediatric-onset multiple sclerosis (POMS).” PMID 36169959 ↗ Sep 2022 “Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis.” NCT02981082 ↗ “Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation” PMID 38296965 ↗ Jan 2024 “Dimethyl fumarate (DMF) standard scheme” NCT04263610 ↗ “BG00012 (DMF) (Tecfidera®.)” NCT02683863 ↗ “LAS41008 (containing DMF)” NCT02955693 ↗ |
| Known as | DR-DMF | “Delayed-release dimethyl fumarate (DR-DMF) has cytoprotective and antiinflammatory properties and has recently been approved in the United States as an oral treatment for...” PMID 24139424 ↗ Oct 2013 |
| Known as | LAS41008 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01726933 ↗ |
| Known as | Tecfidera (dimethyl fumarate) | “Tecfidera (dimethyl fumarate)” NCT03535298 ↗ |
| Known as | Tecfidera. | “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 ↗8“TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.” NCT02901106 ↗ “Dimethyl fumarate (Tecfidera®) treatment is initiated by daily administration of 120 mg Tecfidera® p.o. in the morning in week 0.” NCT02461069 ↗ “Patients will receive oral administration of Dimethyl Fumarate (Tecfidera™) 120 mg twice a day for the first week” NCT04292080 ↗ “BG00012 (DMF) (Tecfidera®.)” NCT02683863 ↗ “TECFIDERA® capsules” NCT02201849 ↗ |
| Action | Inhibit | “we confirmed the NF-κB-inhibiting mechanism of DMF in the blood” PMID 37217183 ↗ Aug 2023 |
| Route | Oral | “BG-12 (dimethyl fumarate) is an oral agent approved in the United States for the treatment of relapsing forms of MS.” PMID 24131282 ↗ Oct 2013 |