Tecfidera

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…

Age is a main driver of disability in multiple sclerosis (MS) and has a key influence on patients’ therapeutic responses to Tecfidera (dimethyl fumarate) and Tysabri (natalizumab), a study showed. Given those findings, age should be considered in the risk/benefit assessment that’s used in the decision-making process for…

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…

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…

Lupin‘s generic equivalent of Tecfidera has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS), the company announced in a press release. The therapy — dimethyl fumarate delayed-release capsules — is indicated for use in people with clinically…

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…

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…

Bafiertam (monomethyl fumarate), a bioequivalent of Tecfidera to treat relapsing forms of multiple sclerosis (MS), is now available to patients in the U.S. through a network of specialty pharmacies, Banner Life Sciences, the therapy’s developer, announced. Banner previously stated that Bafiertam would arrive on the market…

Mavenclad (cladribine) appears to be better at lowering relapse rates during the first two years of disease in relapsing-remitting multiple sclerosis (RRMS) patients than other MS therapies, including interferon, Copaxone (glatiramer acetate) and Tecfidera (dimethyl fumarate), a head-to-head observational study found. Mavenclad, however, was less effective at…

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 —…

A protein known as Gsta4 is critical in the growth and activity of oligodendrocytes, a special type of brain cell that generates the myelin sheath that is damaged in multiple sclerosis (MS), a study shows. The overproduction of Gsta4 in…

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…

Rituximab is more effective and leads to fewer treatment discontinuations in people with multiple sclerosis (MS) than Gilenya (fingolimod) and Tecfidera (dimethyl fumarate), according to real-world data based on two years of therapy. Rituximab’s effectiveness appeared to be comparable to that of Tysabri (natalizumab), but with fewer…

About 20%, or 1 in 5, multiple sclerosis (MS) patients fail to adhere to oral disease-modifying therapies (DMTs) taken each day, and about 1 in 4 stop using a prescribed daily oral treatment within one year, a study based on reported real-world use found. The study “Real-world adherence to,…

Banner Life Sciences announced that Bafiertam (monomethyl fumarate) will become available to adults with relapsing forms of multiple sclerosis (MS) in the United States beginning in September. The U.S. Food and Drug Administration (FDA) approved Bafiertam in April as a bioequivalent to Biogen’s Tecfidera…

Tecfidera (dimethyl fumarate) is as safe and effective in Hispanic/Latino multiple sclerosis (MS) patients as it is in their non-Hispanic and non-Latino peers, three-year data from a real-world study show. These interim findings, based on the largest group of Tecfidera-treated Hispanic and Latino MS patients studied to date, support the therapy’s…

Tecfidera (dimethyl fumarate) is safe and effective as a long-term treatment for relapsing-remitting multiple sclerosis (RRMS), a study of clinical trial data covering up to 11 years of treatment suggests. The study, “Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis:…

Generic formulations of dimethyl fumarate — currently sold as Tecfidera by Biogen — were given a green light to enter the U.S. market, after a federal court invalidated a patent protecting Tecfidera from generic competition as a multiple sclerosis (MS) treatment.  The ruling by the District Court for the…

Biogen has released new data on several of its therapies for multiple sclerosis (MS), including Vumerity (diroximel fumarate), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab). The data — six presentations — originally were to be presented at the 2020 annual conference of the American…

The U.S. Food and Drug Administration (FDA) has given final approval to Banner Life Sciences’ Bafiertam (monomethyl fumarate), a bioequivalent alternative to Biogen’s Tecfidera (dimethyl fumarate) to treat people with relapsing…

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to combinations of VTS-Aspirin plus fumarate therapy using Vumerity (diroximel fumarate) or Bafiertam (monomethyl fumarate) for easing flush in patients with relapsing-remitting multiple sclerosis (RRMS). In the U.S., orphan drug designation is given to…

Prescriptions of Roche’s Ocrevus (ocrelizumab) among multiple sclerosis (MS) patients initiating or switching a disease-modifying therapy (DMT) continue to rise in Europe, according to a survey conducted by Spherix Global Insights. Ocrevus, an anti-CD20 monoclonal antibody administered directly into a vein, was approved in the European Union to treat active forms…

Immune cells from patients with relapsing-remitting multiple sclerosis (RRMS) respond differently to Tecfidera (dimethyl fumarate) based on age, gender, and serum blood glucose levels, a study found.  The results suggest these patient-specific factors can modulate the response of immune cells, and should be…

Vitalis will soon test VTS-72, a new formulation of fumarate and VTS-Aspirin, in a Phase 3 trial as a treatment for flushing — facial redness, itching or rash — in patients with relapsing-remitting multiple sclerosis (RRMS). Flushing is a common side effect of an oral MS therapy called…

Vumerity (diroximel fumarate) carries fewer and less severe gastrointestinal side effects compared to Tecfidera (dimethyl fumarate), new data from a Phase 3 trial directly comparing the GI tolerability of these two relapsing-remitting multiple sclerosis (RRMS) treatments show. These results were presented at the 27th Annual Meeting of the European Charcot Foundation,…

The National Multiple Sclerosis Society has criticized Biogen for the $88,000 yearly list price it placed on Vumerity (diroximel fumarate), the newly approved oral disease-modifying treatment (DMT) for relapsing multiple sclerosis. That criticism extends to repeated price increases with Tecfidera (dimethyl fumarate), Biogen’s similar oral DMT for…

A twice-daily dosing schedule and side effects like nausea and flushing are key reasons why more than 10% of multiple sclerosis (MS) patients followed for a year stopped using Tecfidera (dimethyl fumarate) as prescribed, a single-site study reports. Adherence to treatment is key to patients’ health, and doctors should not…

Vitalis is planning to open a pivotal clinical trial into its new formulation of fumarate, called VTS-72, that has shown promise in easing flushing — a common and troublesome side-effect of Tecfidera (dimethyl fumarate), an oral treatment for relapsing-remitting multiple sclerosis (RRMS). The company announced plans to…

New 10-year data from the Phase 3 ENDORSE trial confirms the long-term benefits of Biogen’s Tecfidera for patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of this disease. Real-world data from another study also showed Tecfidera to be superior to several other disease-modifying therapies for relapsing MS,…