December 22, 2023 News by Mary Chapman Generics of Tecfidera not available in Europe until at least 2025 The European Commission (EC) has withdrawn its marketing authorizations for generic versions of Tecfidera (dimethyl fumarate), an oral therapy approved in Europe for relapsing-remitting multiple sclerosis (RRMS). According toĀ Biogen, which developed and markets the brand-name medication, the decision ensures Biogen will have full data and marketing protection…
August 1, 2023 News by Steve Bryson, PhD Tecfidera confirmed safe, effective in Black and Hispanic MS patients Treatment with Tecfidera (dimethyl fumarate) provides a similar long-term benefit for Black and Hispanic people with multiple sclerosis (MS) as is found in other racial and ethnic populations, according to five years of data from the real-world ESTEEM study. The study ā which assessed the long-term safety and…
December 14, 2022 News by Joana Vindeirinho, PhD Tecfidera Has No Impact on PPMS Progression After 2 Years: Trial Data Continuous treatment with Tecfidera (dimethyl fumarate) for more than two years did not slow clinical and radiological measures of disease progression in people with primary progressive multiple sclerosis (PPMS) compared with patients who started treatment after one year. In fact, most PPMS patients remained stable with or without…
November 1, 2022 News by Marta Figueiredo, PhD #ECTRIMS2022 ā Tecfidera Lowers Risk of 1st Symptoms in RIS in Trial Treatment with Tecfidera (dimethyl fumarate) significantly reduces the risk of experiencing the first multiple sclerosis (MS) symptoms in adults with radiologically isolated syndrome (RIS), according to data from a Phase 4 clinical trial. RIS is a condition in which patients have MS-like lesions on MRI scans, but…
October 10, 2022 News by Marisa Wexler, MS Tecfidera Works Better Than Avonex to Ease MS in Children in Trial Among children and adolescents with multiple sclerosis (MS), treatment with Tecfidera (dimethyl fumarate) resulted in less disease activity on MRI scans and fewer relapses, compared with Avonex (interferon beta-1a), according to new data from the CONNECT Phase 3 trial. Researchers noted the lack of disease-modifying therapies…
July 18, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: ATA188 in Progressive MS, Early Symptoms, Yoga, Rituximab EMBOLD Study of ATA188 in Progressive MS Is Given Go-ahead Is this another small step toward an MS cure? AT188 is an experimental therapy designed to kill cells infected with the Epstein-Barr virus (EBV). As you probably know, researchers have found a lot of evidence that EBV is connected…
July 15, 2022 News by Marisa Wexler, MS Rituximab Outperforms Tecfidera at Preventing Relapses in Phase 3 Trial Multiple sclerosis (MS) patients treated with rituximab were more than five times less likely to experience a relapse compared with patients given Tecfidera (dimethyl fumarate), according to data fromĀ a Phase 3 clinical trial. Patients on the experimental therapy also were 32% more likely to have no evidence…
July 13, 2022 News by Steve Bryson, PhD For MS Patients in Japan, Kesimpta May Be Best at Preventing Relapses Kesimpta (ofatumumab) may be more effective at reducing relapse rates than other disease-modifying therapies (DMTs) in Japanese adults with relapsing forms of multiple sclerosis (MS), according to a review of clinical trial data. Although the differences were not statistically significant, the study provided comparative evidence that may help…
June 23, 2022 News by Marta Figueiredo, PhD Biogen Secures Tecfidera Patent in EU Until 2028; Generics Not Likely Biogen has secured a new patent in Europe covering the use of its oral therapy TecfideraĀ (dimethyl fumarate) for multiple sclerosis (MS) through 2028, the company announced. Granted by the European Patent Office, patent EP2653873 covers the composition and use of dimethyl fumarate at a dose of 480…
June 10, 2022 News by Steve Bryson, PhD No Thyroid Problems With DMF Therapy, Records Study Concludes Treatment with the approved multiple sclerosis (MS) therapy dimethyl fumarate (DMF) did not affect the function of the thyroid gland, an organ that secretes hormones to regulate metabolism, a medical records study concluded. Screening for thyroid problems is not needed for people with MS considered for DMF therapy, the…
May 31, 2022 News by Marta Figueiredo, PhD Mayzent and Kesimpta Gaining Ground as MS Treatments in Canada Novartisā Mayzent (siponimod) and Kesimpta (ofatumumab) are gaining ground among multiple sclerosisĀ (MS) therapies in Canada, according to the latest Spherix Global Insightsā report. āFollowing an eventful 2021 that included the launch of two new brands ā Novartisā Kesimpta and BMS’ Zeposia ā and generic versions of Biogenās…
April 14, 2022 News by Marisa Wexler, MS Vumerity Added to NHS of England for People With Active RRMS The National Institute for Health and Care Excellence (NICE) has added oralĀ Vumerity (diroximel fumarate), approved to treatĀ relapsing-remitting multiple sclerosisĀ (RRMS) in the U.K., to the list of medications available through the public health program for England. Because the therapy has been recommended through a fast track appraisal process, Vumerity…
March 2, 2022 News by Marisa Wexler, MS #ACTRIMS2022 ā Algorithm Predicts Relapse Risk Using EHR Data Using a two-step machine learning strategy, researchers have developed an algorithm to predict the risk of multiple sclerosis (MS) relapse based on data gleaned from electronic health records. “The two-step machine learning model predicts a patient’s future one-year MS relapse risk with clinically actionable accuracy, comparable to other clinical…
February 28, 2022 News by Marisa Wexler, MS #ACTRIMS2022 ā Mavenclad Best at Reducing Relapses: Real-world Data People with multiple sclerosis (MS) who are treated with Mavenclad (cladribine) are less likely to experience a disease relapse than those who are treated with Gilenya (fingolimod), Tecfidera (dimethyl fumarate), or Aubagio (teriflunomide), according to an analysis of real-world data. The findings were presented at the Americas Committee…
February 9, 2022 News by Marisa Wexler, MS Vumerity Added to NHS of Scotland for People With Active RMMS Note: An earlier version of this story stated the Scottish Medicines Consortium approved Vumerity for RRMS patients in that country. The consortium decides to add a medicine to Scotlandās National Health Service; the MHRA approves treatments for England, Scotland, and Wales. The Scottish Medicines Consortium has approved adding the…
January 24, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: MRSI, Acthar Gel, Tecfidera vs. Gilenya, Exergames Imaging Brain Metabolites May Help Diagnose, Monitor MS Have you ever heard of magnetic resonance spectroscopic imaging, or MRSI? I hadn’t until I read this story. It’s a technique that in concept allows a radiologist to see metabolites in the brain. Metabolites are small molecules that are produced during…
January 21, 2022 News by Margarida Maia, PhD Real-World Data Shows Tecfidera Comparable to Gilenya at Preventing Relapses Tecfidera (dimethyl fumarate) appears to have similar benefits to Gilenya (fingolimod) in preventing relapses and the loss of motor function and cognition in people with multiple sclerosis (MS), a study with real-world data found. The two medications also led to similar findings on MRI scans, including in…
December 8, 2021 News by Marisa Wexler, MS Report: Tecfidera, Aubagio Preferred RRMS Treatments in Canada Tecfidera (dimethyl fumarate) and Aubagio (teriflunomide) are the preferred disease-modifying treatments for managing relapsing-remitting multiple sclerosis (RRMS) in Canada, according to a report from Spherix Global Insights. The report was part of SpherixāsĀ RealTime Dynamix: Multiple Sclerosis (Canada) service, which collects data on market trends of MS…
November 17, 2021 News by Marisa Wexler, MS Vumerity Approved for RRMS in European Union The oral medication Vumerity (diroximel fumarate) has been approved by the European Commission to treat adults with relapsing-remitting multiple sclerosis (RRMS). “This approval is a significant step forward in improving treatment adherence for people living with relapsing MS, which can make a meaningful difference on treatment…
November 15, 2021 Columns by Ed Tobias MS News That Caught My Eye Last Week: NVG-291, Ocrevus, Tolebrutinib, Tecfidera Nerve Repair Therapy NVG-291 Safe, Well-tolerated in Healthy People This experimental therapy has a long way to go before it becomes reality. But it’s encouraging that this first step found NVG-291’s side effects to be mild and short-lasting. NVG-291 is designed to promote remyelination by modulating an enzyme called…
November 10, 2021 News by Marisa Wexler, MS Study Sheds Light on How Tecfidera Kills Immune Cells The multiple sclerosis (MS) treatment Tecfidera (dimethyl fumarate) triggers immune cell death by interacting with a protein called Keap-1, a new study reveals. The study, “Wdr1 and cofilin are necessary mediators of immune-cell-specific apoptosis triggered by Tecfidera,” was published inĀ Nature Communications. Tecfidera is widely…
October 13, 2021 News by Marisa Wexler, MS #ECTRIMS2021 ā Rituximab as First RRMS Therapy Outperforms Others Editorās note: TheĀ Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13ā15. GoĀ here to see the latest stories from the…
September 20, 2021 News by Marisa Wexler, MS Vumerity Recommended for EU Approval as RRMS Treatment A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosisĀ (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…
July 13, 2021 News by Somi Igbene, PhD Patients Less Likely to Stop Taking Tecfidera Than Aubagio: Study Tecfidera has a lower risk of discontinuation due to treatment failure than Aubagio in people with multiple sclerosis (MS), a new observational study in Norway suggests. In the study, people receiving Tecfidera (dimethyl fumarate) were 38% less likely to experience treatment failure and stop use than those receiving…
June 3, 2021 News by Aisha I Abdullah PhD NfL Promising Biomarker for Predicting Tecfidera Response Low levels of serum neurofilament light chains (sNfL) prior to treatment predicts an optimal response to Tecfidera (dimethyl fumarate) and reduced immune cell overactivity in multiple sclerosis (MS) patients, a study reports. The investigators noted the…
May 5, 2021 News by Marisa Wexler, MS Safety of Oral DMTs for RRMS in Real-world Use Seen to Match Trial Findings People with relapsing-remitting multiple sclerosis (RRMS) using approved oral disease-modifyingĀ therapiesĀ generally tolerate the treatments well, with real-world adverse event profiles similar to those seen in clinical trials, an analysis of U.S. data indicates. Results also suggest high adherence to these therapies ā meaning patients are usually taking the therapies…
April 19, 2021 News by Vanda Pinto, PhD Tecfidera Approved in China to Treat Relapsing MS Tecfidera (dimethyl fumarate) was given the green light by health regulators in China to treat people withĀ relapsing multiple sclerosis (MS) ā clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The National Medical Products Administration’s (NMPA) decisionĀ came through a priority review of clinical trial data for Tecfidera,…
April 13, 2021 News by Margarida Maia, PhD Vumerity Linked to Better Quality of Life Than Tecfidera in RRMS Trial Vumerity (diroximel fumarate) is easier on the gastrointestinal tract than Tecfidera (dimethyl fumarate), and this translates into better quality of life for patients with relapsing-remitting multiple sclerosis (RRMS), a new analysis of EVOLVE-MS-2 trial data has found. The study, āImproved gastrointestinal profile with diroximel fumarate is…
April 7, 2021 News by Marta Figueiredo, PhD Tecfidera, Gilenya and Ocrevus Losing Favor as Switch Therapies in US, Spherix Finds Tecfidera (dimethyl fumarate), Gilenya (fingolimod), and Ocrevus (ocrelizumab) are losing ground to more recent therapies among U.S. multiple sclerosisĀ (MS) patients switching treatment, according to the latestĀ Spherix Global Insightsā report. The launch of MS generics, bioequivalents, and new brands in the U.S. market over the past year has increased…
January 29, 2021 News by Marta Figueiredo, PhD Tecfidera Safe and Effective Over Long Term in Children With RRMS, Trial Shows Long-term treatment with TecfideraĀ (dimethyl fumarate)Ā safely and effectively reduces the frequency of relapses in children with relapsing-remitting multiple sclerosis (RRMS), according to 2.5 years of data from the FOCUS Phase 2 trial and its extension study. These findings are consistent with those previously reported for adult patients, supporting…