A new low-cost version of Tecfidera, a widely used oral therapy for relapsing forms of multiple sclerosis (MS), is now available in the U.S. for a fraction of the typical cost. Launched by Civicascript, this generic form of dimethyl fumarate is expected to significantly improve access to…
Tecfidera
Treatment with Tecfidera (dimethyl fumarate) significantly reduces relapse rates for people with multiple sclerosis (MS), and most MS patients on the approved therapy remain free from disability progression for several years. That’s according to a final analysis from the Phase 4 ESTEEM clinical trial (NCT02047097), which tracked…
Combining the approved medication Tecfidera (dimethyl fumarate) with targeted therapy using a patient’s own immune cells may eventually be a promising way of treating multiple sclerosis (MS), according to recent research. The targeted therapy uses tolerogenic dendritic cells (tolDCs), which are being tested in clinical trials, to make…
The European Commission (EC) has withdrawn its marketing authorizations for generic versions of Tecfidera (dimethyl fumarate), an oral therapy approved in Europe for relapsing-remitting multiple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 to Biogen, which developed and markets the brand-name medication, the decision ensures Biogen will have full data and marketing protection…
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 — which assessed the long-term safety and…
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…
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…
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…
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…
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 from a Phase 3 clinical trial. Patients on the experimental therapy also were 32% more likely to have no evidence…
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…
Biogen has secured a new patent in Europe covering the use of its oral therapy Tecfidera (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…
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…
Novartis’ Mayzent (siponimod) and Kesimpta (ofatumumab) are gaining ground among multiple sclerosis (MS) therapies in Canada, according to the latest Spherix Global Insights’ report. “Following an eventful 2021 that included the launch of two new brands — Novartis’ Kesimpta and BMS’ Zeposia — and generic versions of Biogen’s…
The National Institute for Health and Care Excellence (NICE) has added oral Vumerity (diroximel fumarate), approved to treat relapsing-remitting multiple sclerosis (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…
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…
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…
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 Scotland’s National Health Service; the MHRA approves treatments for England, Scotland, and Wales. The Scottish Medicines Consortium has approved adding the…
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…
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…
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 Spherix’s RealTime Dynamix: Multiple Sclerosis (Canada) service, which collects data on market trends of MS…
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…
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…
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 in Nature Communications. Tecfidera is widely…
Editor’s note: The 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. 13–15. Go here to see the latest stories from the…
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 sclerosis (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…
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…
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…
People with relapsing-remitting multiple sclerosis (RRMS) using approved oral disease-modifying therapies 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 — meaning patients are usually taking the therapies…
Tecfidera (dimethyl fumarate) was given the green light by health regulators in China to treat people with relapsing multiple sclerosis (MS) — clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The National Medical Products Administration’s (NMPA) decision came through a priority review of clinical trial data for Tecfidera,…