Biogen

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17–22. Go here to read the latest stories from the conference. Treatment with Tysabri (natalizumab) can improve mental and social health in people with multiple sclerosis (MS), according to new…

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,…

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, “Improved gastrointestinal profile with diroximel fumarate is…

The European Commission (EC) has approved a new method to administer Tysabri (natalizumab) as a treatment for people with relapsing-remitting multiple sclerosis (RRMS). This new delivery route involves a subcutaneous injection in which Tysabri is injected under the skin. Compared with the previously approved intravenous (into the bloodstream) formulation,…

Off-label treatment with Tysabri (natalizumab) significantly lessens disease activity and reduces the number of relapses per year in patients with pediatric-onset multiple sclerosis (POMS), real-world data from Portugal show. The treatment also was considered safe in this population, in agreement with earlier studies. These findings support the usefulness…

Patients with multiple sclerosis (MS) switching from Tysabri (natalizumab) to moderate-efficacy disease-modifying therapies (DMTs) are at a higher risk of showing signs of MS activity and experiencing disability progression than those switching to high-efficacy DMTs, a real-world study found. Based on these findings, the researchers are arguing that,…

The number of cases of Tysabri (natalizumab) that are associated with progressive multifocal leukoencephalopathy (PML) — a serious brain infection — in multiple sclerosis (MS) patients living in Sweden fell between 2006 and 2018, a study shows. Notably, the data highlighted that this drop was likely due to…

Treatment with rituximab before or during pregnancy was not associated with major pregnancy or infant complications, according to a case series of 19 women with multiple sclerosis (MS) and other autoimmune diseases. These findings add to the limited available evidence on the use of rituximab by expectant mothers either…

FDA Approves Plegridy as Intramuscular Injection for Relapsing MS A common patient complaint about Plegridy has been that its subcutaneous injection procedure results in injection site reactions. This new formulation is delivered into the muscle, rather than under the skin. The needle is longer, but Biogen pharmaceuticals thinks the…

The U.S. Food and Drug Administration (FDA) has approved an intramuscular injection formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing forms of multiple sclerosis (MS). This formulation, for injection directly into muscle, is what is typically used to deliver the flu shot. According to Biogen, Plegridy’s…

Long-term treatment with Tecfidera (dimethyl fumarate) 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…

Researchers from the Kessler Foundation will launch a new study investigating the effects of Tysabri (natalizumab) on cognitive fatigue — the type of fatigue that happens after strong mental concentration, such as in problem-solving — in people with relapsing-remitting multiple sclerosis (RRMS). Cognitive fatigue, which is very…

The European Commission (EC) has approved a new, intramuscular formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing-remitting multiple sclerosis (RRMS). This new mode of administration — in which Plegridy is directly injected into the muscle, rather than under the skin (subcutaneously) — does…

Tecfidera (dimethyl fumarate) may be an effective treatment option for patients with early relapsing forms of multiple sclerosis (MS) who fail to respond adequately to glatiramer acetate, according to a post-hoc analysis of an observational study. The findings were reported in an article, “Effectiveness…

Tysabri Affects Immune System Beyond Known MS Target, Study Finds Tysabri (natalizumab) slows multiple sclerosis progression by blocking some immune cells from entering the central nervous system, where they attack the myelin coating of nerves. Yet this study shows that Tysabri may also significantly reduce the number of proteins…

Tecfidera (dimethyl fumarate) was detected in the breast milk of two women using the oral therapy to treat their multiple sclerosis, but at concentrations well below the “theoretical threshold of concern” for an infant, a case study reported. According to its investigators, this is the first…

The levels of the protein neurofilament light chain (NfL) in the blood when a person experiences a first demyelinating event associated with multiple sclerosis (MS) can predict brain atrophy up to a decade later, a new study shows. Titled “Association of Serum Neurofilament Light Levels…

Treatment with Tysabri (natalizumab) was more effective than Gilenya (fingolimod) in helping people with relapsing–remitting multiple sclerosis (RRMS) achieve no evidence of disease activity, a head-to-head study suggested. The study, “BEST-MS: A prospective head-to-head comparative study of natalizumab and fingolimod in active relapsing MS,” was…

Phase 3 Trial of Sativex, Cannabis Extract Treatment for MS Spasticity, Opens in US This is a major step toward making a clinically tested, cannabis-based medication available in the U.S. I’ve always thought that medications containing a THC/CBD combination are useful to lessen some MS symptoms, but the lack…

Adults with active relapsing-remitting multiple sclerosis (RRMS) treated with Tysabri (natalizumab) had fewer new and accumulated lesions, and a lower relapse rate than those treated with Gilenya (fingolimod) for 24 weeks, according to…

MD1003 Fails to Prevent Disability Progression in Progressive MS Patients, Trial Shows This is discouraging news for people taking high-dose biotin, many who have been buying it over the counter. Not only do these researchers report that taking 100 mg of biotin (MD1003) three times a day failed to…

Biogen is discontinuing the clinical development of opicinumab, its experimental treatment candidate for multiple sclerosis (MS), based on data from the Phase 2 AFFINITY clinical trial. The announcement, amid a third-quarter report, indicated that the study failed to meet both its main and secondary goals, without further details. The trial,…

Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are similarly effective at lowering the frequency of relapses and delaying disability progression in people with relapsing-remitting multiple sclerosis (RRMS), a real-world study from Switzerland reported. These efficacy measures were also consistent whether patients were new to a disease-modifying therapy (DMT)…

The U.S. Food and Drug Administration (FDA) has approved Cipla’s dimethyl fumarate capsules, a generic version of Biogen’s Tecfidera, to treat adults with relapsing forms of multiple sclerosis (MS), the company announced in a press release. This generic is packaged as 120 mg or 240 mg…

Last week, I again started my twice-annual infusion of Rituxan (rituximab). After 384 days without my disease-modifying therapy, my team decided I could no longer wait. In its absence, my symptomology had worsened. Halting progression trumped a pandemic, and with personal protective equipment in place, I begin…

Long-term treatment with Tecfidera (dimethyl fumarate) continues to be safe and effective at reducing the frequency of relapses and disability progression in patients with relapsing-remitting multiple sclerosis (RRMS), according to 13-year data from a Phase 3 extension study. The study findings were presented at MSVirtual2020 by Ralf…

Ocrevus (ocrelizumab), a second-generation anti-CD20 antibody, may be associated with a greater risk of infections. But it carries a lower risk of cancer and immune reactions than first-generation rituximab in people with multiple sclerosis (MS), according to a real-life study. The higher incidence of infections linked with Ocrevus’…

FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS The U.S. Food and Drug Administration’s approval of Kesimpta (ofatumumab) this month is a pretty big deal. Kesimpta is a once-a-month injectable disease-modifying therapy. There’s nothing else like it, because Kesimpta targets B-cells in the immune system. Until now, only…

Mylan announced the launch of a first generic version of Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS). The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid —…

Almost two-thirds of people newly diagnosed with multiple sclerosis (MS) in the United States, identified through a national database, were not prescribed disease-modifying therapies (DMTs) over an average of more than two years of follow-up, a real-world study of nearly 5,700 patients found. Current guidelines “recommend early treatment with…