January 27, 2021 News by Teresa Carvalho, MS Age Found to Be Main Driver of MS Disability, Patient Therapy Response 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…
December 2, 2020 News by Joana Carvalho, PhD Tecfidera May Be Effective Option for Relapsing MS Patients Who Fail to Respond to Glatiramer Acetate 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, āEffectiveness…
November 24, 2020 News by Aisha I Abdullah PhD Tecfidera Found in Breast Milk But Levels Appear Safe, Case Study Reports 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…
October 8, 2020 News by Sara Guariglia FDA Approves Lupin’s Generic Form of Tecfidera for MS Treatment Lupin‘s generic equivalent ofĀ Tecfidera has been approved by the U.S. Food and Drug Administration (FDA) for the treatment ofĀ multiple sclerosis (MS), the company announced in a press release. The therapy ā dimethyl fumarate delayed-release capsules ā is indicated for use in people withĀ clinically…
October 5, 2020 News by Marisa Wexler, MS Gilenya and Tecfidera Similarly Effective at Treating RRMS, Real-world Study Says 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 aĀ disease-modifying therapy (DMT)…
September 29, 2020 News by Joana Carvalho, PhD FDA Approves Generic of Tecfidera for Adults With Relapsing MS The U.S. Food and Drug Administration (FDA) has approved Ciplaās dimethyl fumarate capsules, a generic version of Biogenās Tecfidera, to treat adults with relapsing forms of multiple sclerosis (MS), the company announced in aĀ press release. This generic is packagedĀ as 120 mg or 240 mg…
September 16, 2020 News by Joana Carvalho, PhD #MSVirtual2020 – 13-year Data Find Tecfidera Safe, Reduces RRMS Relapses 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 sclerosisĀ (RRMS), according to 13-year data from a Phase 3 extension study. The study findings were presented at MSVirtual2020 by Ralf…
September 8, 2020 News by Joana Carvalho, PhD Bafiertam, Oral Relapsing MS Therapy, Arrives in US Bafiertam (monomethyl fumarate), a bioequivalent of TecfideraĀ 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 therapyās developer, announced. Banner previously stated that Bafiertam would arrive on the market…
August 25, 2020 News by Patricia Inacio, PhD Mavenclad Effectively Lowers Relapse Rates, Study Comparing DMTs Finds MavencladĀ (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…
August 20, 2020 News by Marisa Wexler, MS Mylan Launching Tecfidera Generic in US 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 ā…
August 18, 2020 News by Steve Bryson, PhD Gsta4 Protein Promotes Myelin Repair, Prevents Symptoms in MS Rat Model 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…
August 14, 2020 News by Forest Ray PhD 35% of Newly Diagnosed Patients Given DMT in Follow-up Years, US Study Finds 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…
August 11, 2020 News by Marta Figueiredo, PhD Rituximab More Effective Than Gilenya, Tecfidera, and Comparable to Tysabri, Study Finds Rituximab is more effective and leads to fewer treatment discontinuations in people with multiple sclerosisĀ (MS)Ā than Gilenya (fingolimod) and Tecfidera (dimethyl fumarate), according to real-world data based on two years of therapy. Rituximabās effectiveness appeared to be comparable to that of Tysabri (natalizumab), but with fewer…
August 10, 2020 News by Patricia Inacio, PhD 1 in 5 MS Patients Don’t Adhere to Daily Oral DMTs, Real-world Study Finds About 20%, or 1 in 5,Ā 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 āReal-world adherence to,…
July 20, 2020 News by Forest Ray PhD Bafiertam, for Adults With Relapsing MS, Available in US in September Banner Life Sciences announced thatĀ 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 AdministrationĀ (FDA)Ā approved Bafiertam in April as a bioequivalent to BiogenāsĀ Tecfidera…
July 6, 2020 News by Marta Figueiredo, PhD Tecfidera Safe and Effective in Hispanic/Latino MS Patients, Real-world Data Show TecfideraĀ (dimethyl fumarate) is as safe and effective in Hispanic/LatinoĀ multiple sclerosisĀ (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 therapyās…
June 29, 2020 News by Marisa Wexler, MS Tecfidera Safe and Effective Over Years of Use, RRMS Study Finds 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:…
June 23, 2020 News by InĆŖs Martins, PhD US Court Rules in Favor of Mylan, Generic Version of Tecfidera Generic formulations of dimethyl fumarateĀ ā currently sold as Tecfidera by BiogenĀ ā were given a green light to enter the U.S. market, after a federal courtĀ invalidated a patent protecting Tecfidera from generic competition as aĀ multiple sclerosisĀ (MS) treatment.Ā The ruling by the District Court for the…
May 20, 2020 News by Marisa Wexler, MS Biogen Presents Update on its MS Therapeutic Portfolio 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 ā six presentations ā originally were to be presented at the 2020 annual conference of the American…
May 5, 2020 News by Steve Bryson, PhD FDA Approves Bafiertam, Tecfidera Bioequivalent, for Relapsing MS The U.S. Food and Drug Administration (FDA) has given final approval toĀ Banner Life Sciencesā Bafiertam (monomethyl fumarate),Ā a bioequivalent alternative to Biogenās Tecfidera (dimethyl fumarate) to treat people with relapsing…
April 23, 2020 News by InĆŖs Martins, PhD VTS-Aspirin Combos to Ease Flush in RRMS Named Orphan Drug by FDA The U.S. Food and Drug Administration (FDA) has granted orphan drug status to combinations of VTS-Aspirin plus fumarate therapy usingĀ Vumerity (diroximel fumarate) or Bafiertam (monomethyl fumarate) for easing flush in patients with relapsing-remitting multiple sclerosisĀ (RRMS). In the U.S., orphan drug designation is given to…
April 14, 2020 News by Marta Figueiredo, PhD Ocrevus Use Still Growing in Europe But Challenges on Horizon, Spherix Reports Prescriptions ofĀ RocheāsĀ OcrevusĀ (ocrelizumab) among multiple sclerosis (MS) patients initiating or switching aĀ disease-modifying therapy (DMT) continue to rise in Europe, according toĀ a surveyĀ conducted byĀ Spherix Global Insights. Ocrevus, an anti-CD20 monoclonal antibody administered directly into a vein,Ā was approved in the European UnionĀ to treat active forms…
February 25, 2020 News by Steve Bryson, PhD Age, Gender, Blood Glucose Affect Immune Cells’ Response to Tecfidera in RRMS Patients, Study Reports Immune cells from patients withĀ relapsing-remitting multiple sclerosis (RRMS) respond differently to Tecfidera (dimethyl fumarate) based on age, gender, and serum blood glucose levels, a study found.Ā The results suggest these patient-specific factors can modulate the response of immune cells, and should be…
January 10, 2020 News by Catarina Silva Vitalis Plans to Launch Phase 3 Trial Testing VTS-72 as Treatment for RRMS-related Flushing Vitalis will soon test VTS-72, a new formulation of fumarate and VTS-Aspirin, in a Phase 3 trial as a treatment for flushing ā facial redness, itching or rash ā in patients with relapsing-remitting multiple sclerosisĀ (RRMS). Flushing is a common side effect of an oral MS therapy called…
November 26, 2019 News by Patricia Inacio, PhD GI Symptoms with Vumerity Fewer and Milder Than Tecfidera, Phase 3 Trial Shows Vumerity (diroximel fumarate) carries fewer and less severe gastrointestinal side effects compared toĀ TecfideraĀ (dimethyl fumarate), new data from a Phase 3 trial directly comparing the GI tolerability of these twoĀ relapsing-remitting multiple sclerosisĀ (RRMS) treatments show. These results were presented at the 27thĀ Annual Meeting of the European Charcot Foundation,…
November 14, 2019 News by Grace Frank Vumerity’s $88,000 List Price Not What ‘We Had Hoped,’ National MS Society Says The National Multiple Sclerosis Society has criticized BiogenĀ for the $88,000 yearly list price it placed onĀ VumerityĀ (diroximel fumarate), the newly approved oral disease-modifying treatment (DMT) for relapsing multiple sclerosis. That criticism extends to repeated price increases withĀ TecfideraĀ (dimethyl fumarate), Biogen’s similar oral DMT for…
October 25, 2019 News by Ana Pena PhD Twice Daily Dosing and Side Effects Top Reasons Patients Seen to Stop Tecfidera in Small Study A twice-daily dosing schedule and side effects like nausea and flushing are key reasons why more than 10% ofĀ multiple sclerosis (MS) patients followed for a year stopped usingĀ Tecfidera (dimethyl fumarate) as prescribed, a single-site study reports. Adherence to treatment is key to patients’ health, and doctors should not…
October 24, 2019 News by Ana Pena PhD Potential RRMS Fumarate Treatment Free of ‘Flush’ Effect to Enter Trial in 2020, Vitalis Says VitalisĀ is planning to open a pivotal clinical trial into its new formulation of fumarate, calledĀ VTS-72, that has shown promise in easing flushing ā a common and troublesome side-effect of Tecfidera (dimethyl fumarate), an oral treatment for relapsing-remitting multiple sclerosis (RRMS). The company announced plans to…
September 11, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – 10-year Data Confirm Long-term Benefits of Biogen’s Tecfidera for RRMS New 10-year data from the Phase 3 ENDORSE trial confirms the long-term benefits of Biogenās TecfideraĀ for patients with relapsing-remitting multiple sclerosisĀ (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,…
August 30, 2019 Columns by Ed Tobias Another Study Shows That Costs of Disease-modifying Therapies Are Zooming It probably comes as no surprise to you that the costs of some of the most popular MS medications have been soaring. A new study by researchers at the University of Pittsburgh reports that their list prices have more than quadrupled in a decade. And out-of-pocket costs rose even more.