January 11, 2018 News by Patricia Silva, PhD Newly Diagnosed MS Patients Stay Longer on Rituxan Than Other Therapies, Study Finds Multiple sclerosis patients whose first treatment is Genentech'sĀ Rituxan (rituximab) stay on it longer than other disease-modifying drugs that patients start with, a Swedish study reports. When they stop taking Rituxan, Ā it usually isn't for lack of effectiveness or side effects...
December 15, 2017 News by Patricia Silva, PhD Ocrevus’ Use Continues Rising, with RRMS Patients Receiving the Most Attention U.S. neurologists are increasingly prescribing Genentech’s Ocrevus (ocrelizumab) to their multiple sclerosis patients, Spherix Global InsightsĀ reports. Another good sign for Genentech is that, in just three months, neurologists have increased by 50 percent their estimate of the numbers of relapsing-remitting MS patients who could benefit from Ocrevus.
November 29, 2017 News by Alice MelĆ£o, MSc Alkermes, Biogen Partnering on Therapy for Relapsing Forms of Multiple Sclerosis AlkermesĀ and BiogenĀ have begun working together on a compound known asĀ ALKS 8700Ā as a potential treatment for relapsing forms of multiple sclerosis. Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing. ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS. Aikermes designed it to have better features thanĀ Tecfidera (dimethyl fumarate)Ā ā in particular, fewer gastrointestinal side effects. The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales. Aikermes is evaluating ALKS 8700's safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS. Preliminary results of the EVOLVE-MS-1 trial, which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus. Aikermes discussed the treatments safety, and patients' ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS MeetingĀ in Paris in October. The company is still recruiting participantsĀ for a second trial that will compare ALKS 8700 and Tecfidera's effect on the gastrointestinal system. The EVOLVE-MS-2 study will Ā be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018. Ā
November 8, 2017 News by Patricia Silva, PhD Global Phase 3 Trial of Oral Ponesimod Plus Tecfidera Enrolling Relapsing MS Patients Actelion is recruiting about 600 relapsing multiple sclerosis (MS) patients to a Phase 3 trial testing the addition of oral ponesimod to Tecfidera (dimethyl fumarate)Ā in people who continue experiencing relapses while on the treatment. Ponesimod works in a similar way to Novartisā Gilenya (fingolimod) ā making immune…
November 1, 2017 News by Alice MelĆ£o, MSc #MSParis2017 ā EVOLVE-MS-1 Interim Trial Data Shows Alkermes Therapy Safe for Treating Relapsing MS Preliminary data from the Phase 3 EVOLVE-MS-1 trial shows thatĀ ALKS 8700Ā ā an investigative therapy developed byĀ AlkermesĀ to treat relapsing forms of multiple sclerosis ā has a good safety and tolerability profile. ALKS 8700 is an oral compound. Once inside the body, it is rapidly transformed into the therapeutic compound monomethyl fumarate (MMF). Although similar, this drug candidate was designed to offer features different than those achieved with the commercially available Tecfidera (dimethyl fumarate). Alkermes is currently assessing the safety and efficacy of ALKS 8700 in the EVOLVE-MS program, which includes two Phase 3 clinical trials in patients with relapsing-remitting MS. The EVOLVE-MS-1 is a two-year study being conducted in 107 U.S. and European research sites. It will evaluate the long-term safety of ALKS 8700 in some 930 RRMS patients. Interim data collected during the first month of treating 580 participants showed low incidence of GI adverse events, with no reports of serious events. The most common adverse side effects associated with the treatment were flushing, pruritus and diarrhea. Alkermes, which is based in Ireland, said additional results from the initial three months of treatment further supported the positive safety data of ALKS 8700, with only 2.3 percent of patients reporting serious adverse events and 3.7 percent having to stop treatment. The EVOLVE-MS-2 trial, being conducted at 48 U.S. sites, will compare the safety and efficacy of ALKS 8700 versus Tecfidera in RRMS patients. The study is still recruiting participants. Recent data of EVOLVE-MS-2 was also subject of a poster presentation at the ECTRIMS-ACTRIMS Meeting.
October 23, 2017 Columns by Ed Tobias MS News That Caught My Eye Last Week: Mavenclad, Tecfidera, Ublituximab, Ocrevus The giant ECTRIMS/ACTRIMS MS conference begins in Paris on Wednesday, Oct. 25, and this column focuses on several of the presentations on which Multiple Sclerosis News Today will be reporting during the week. #MSParis2017 ā Mavenclad Reduces Relapses, Prevents New Lesions in Many RRMS Patients, Presentations Will…
October 20, 2017 News by Patricia Silva, PhD #MSParis2017 – Alkermes to Give Updates on ALKS 8700 Studies at ECTRIMS-ACTRIMS Meeting Alkermes will showcase its work in developing a treatment that harnesses the effect of Tecfidera (dimethyl fumarate) for relapsing multiple sclerosis (MS), while lowering the risk of stomach problems at the 7th Joint ECTRIMS-ACTRIMS Meeting this month in Paris. The investigational drug, ALKS 8700, uses the same mechanism of action as Tecfidera. By building the molecule in a different way, however, the company expects it will show better tolerability. Once in the body, dimethyl fumarate turns into monomethyl fumarate (MMF), the molecule that actually impacts MS disease processes. But before giving rise to MMF,Ā dimethyl can cause side effects in users, particularly gastrointestinal. In fact, stomach problem were what causedĀ people in Tecfidera Phase 3 trials to stop the treatment. Alkermes uses a so-called prodrug approach to try to overcome this problem. By attaching a different compound to MMF āĀ which breaks away from the molecule once in the body ā Ā it is possible to deliver MMF with lesser gastrointestinal side effects, Phase 1 study data indicate. At the meeting, the company will present two posters on two clinical trials exploring ALKS 8700 in patients with relapsing-remitting MS. The first presentation, will describe a Phase 3 trial that aims to compare ALKS 8700 to Tecfidera in about 420 patients. The trial is primarily concerned with the drugās safety, and will measure the occurrence and impact of gastrointestinal side effects in the two treatment groups. The presentation will only include descriptions of patients characteristics and study design, as outcomes are yet to be analyzed. Patients who complete the Phase 3 trial will be eligible to continue in an ongoing open-label, long-term safety study, called EVOLVE-MS-1, covered in the companyās second presentation. By March 3, 2017, the study had enrolled 543 patients. In addition to describing patient characteristics, researchers will present the rates of discontinuation caused by gastrointestinal adverse events within one month of starting the treatment.
October 16, 2017 News by Patricia Silva, PhD Multiple Sclerosis Therapy Aubagio May Cause Nail Loss, Researchers Report Aubagio (teriflunomide) may lead to reversible nail loss, researchers at Italy'sĀ University of BolognaĀ reported after reviewing the case of a 55-year-old woman with relapsing-remitting multiple sclerosis. They described what happened to a patient who was referred to an MS clinic after experiencing acute optic neuritis ā or inflammation of the optic nerve ā three months earlier.Ā Their report, āNail loss after teriflunomide treatment: A new potential adverse event,āĀ was published in the journal Multiple Sclerosis and Related Disorders. Doctors had been treating the woman with intravenous methylprednisolone. Physicians had judged her slightly disabled, with an Expanded Disability Status Scale (EDSS) score of 3, but had not diagnosed her with MS. When she was diagnosed a few months later, she began receiving interferon beta-1a. It did not work, so doctors switched her to Sanofi Genzyme'sĀ Aubagio. At first, she tolerated the treatment well, having only slight nausea after taking the medication. Physicians did not detect signs of liver toxicity or high blood pressure, which are relatively common side effects of Aubagio. Roughly three months after starting the medication, however, the woman began having more trouble walking problems and had mild hair loss. Two and a half months later, she said her nails had started falling out in the past month. When doctors examined her, she had lost two nails, while others appeared to have stopped growing. They were thinner than normal and some had detached from the nail bed. In addition, her hair loss continued. She had not started using other drugs, new cosmetics, or changed her diet. A dermatologist excluded the possibility that the condition was the result of fungus, psoriasis, or other conditions that could cause nails to fall off. Because doctors suspected that Aubagio could be the cause of the nail loss, they recommended that she stopped taking it. The patient switched to Biogen'sĀ Tecfidera (dimethyl fumarate) after a couple of weeks, and her nails started to grow again. This supported doctorsā idea that Aubagio had caused the nail loss, and that it was reversible. Nail growth is similar to that of hair, researchers said. The patientās reaction could be an unusual version of the same process that makes people lose their hair when taking Aubagio, they said. Since nail loss is not described as a side effect of Aubagio on the medication's label, researchers urged MS specialists to consider the possibility if they see patients with the problem. Ā
August 31, 2017 News by Alice MelĆ£o, MSc Tecfidera Shows Promise as Replacement MS Therapy for Tysabri, Study Shows Tecfidera (dimethyl fumarate) can be a suitable replacement therapy whenĀ Tysabri (natalizumab) is discontinued, keeping low levels of disease activity in patients with relapsing-remitting multiple sclerosis (RRMS), according to a report published in theĀ Journal of Neurology, Neurosurgery & Psychiatry. Several studies have demonstrated the effectiveness and…
August 28, 2017 News by Alice MelĆ£o, MSc RRMS Patients Needed for Phase 3 Trial to Assess Adverse GI Effects of ALKS 8700 Therapy vs. Tecfidera AlkermesĀ is funding a Phase 3 clinical trial evaluating the effects of itsĀ ALKS 8700Ā therapyĀ on the gastrointestinal tracts of relapsing-remitting multiple sclerosis (RRMS) patients,Ā compared toĀ Tecfidera (dimethyl fumarate), according to a news release by the National Multiple Sclerosis Society. ALKS 8700,Ā an orally administrated form of monomethyl fumarate, is still…
July 18, 2017 Columns by Ed Tobias Fighting in Court Over MS Generics Biogen is a big pharmaceutical company that produces a half-dozen MS drugs. Among them are Tysabri, Avonex and Tecfidera. And Biogen is doing all it can to protect its turf, particularly when it comes to its best seller,Ā Tecfidera. Last month the company filed lawsuits against several…
June 23, 2017 News by Janet Stewart, MSc Tecfidera Improves MS Patients’ Work Productivity, Compared with Other Therapies, Study Shows Multiple sclerosis patients taking Tecfidera, or dimethyl fumarate, were more productive at work than those on Copaxone or beta-interferon therapies, according to a study. Tecfidera also increased patients’ quality of life, researchers said. The study covered patients with relapsing-remitting multiple sclerosis, or RRMS. The four beta-interferon treatments wereĀ Avonex, Betaseron, Rebif,…
April 27, 2017 Columns by Tamara Sellman Latest Research Bolsters My Confidence in Using Tecfidera Many life-affecting decisions are made at the time of an MS diagnosis. Top of the list? The moment you decideĀ your course of treatment. In my case, the decision wasĀ entirely up to me. This isn’t typical, I’ve discovered. Many people with MS aren’t…
April 25, 2017 News by Patricia Silva, PhD Latest Tecfidera and Tysabri Data Suggest Treatments Improve MS Outcomes When Used Early Real-world data of treatment with Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) in relapsing multiple sclerosis (MS) patients suggest that treatment at early disease stages improves outcomes and prevents disability development. The studies, presented by Biogen at the American Academy of Neurology 2017 Annual MeetingĀ in Boston, might challenge the…
April 20, 2017 News by Alice MelĆ£o, MSc Early Use of Tecfidera and Tysabri Improves MS Patients’ Outcomes, Studies Suggest The latest results on Tecfidera (dimethyl fumarate) and TysabriĀ (natalizumab) use in a clinical practice setting suggest that early treatment can improve outcomes in multiple sclerosis (MS) patients. This and other recent dataĀ on Tecfidera and Tysabri for the treatment of MS will be presented by BiogenĀ at the…
March 20, 2017 News by Patricia Silva, PhD Alkermes Begins Phase 3 Study of ALKS 8700 as Relapsing MS Treatment AlkermesĀ has started a Phase 3 clinical trial evaluating ALKS 8700, the oral monomethyl fumarate (MMF) prodrug it is developing for the treatment of relapsing forms of multiple sclerosis (MS). The multicenter, double-blind, active-controlled trial (NCT02634307) will examine whether the gastrointestinal tract can tolerate ALKS 8700 better thanĀ Tecfidera…
February 1, 2017 News by admin Tecfidera Use Linked to Liver Injury in MS Patients, but Severe Injury Appears Rare TecfideraĀ (dimethyl fumarate or DMF) use by multiple sclerosis (MS) patients can result in liver injury and, in rare cases, even severeĀ injury, a study found, leading its researchers to recommend that patients’ on this treatmentĀ be carefully monitored for signs of injury. The study, ā…
January 17, 2017 News by Ćzge Ćzkaya, PhD Tecfidera Seen to Potentially Limit Vision Problems in MS Genetically silencing the transcription factor Nrf2 in a mouse model of multiple sclerosis (MS) results in visual deficits, inflammation of the optic nerve, and degeneration of the retinal ganglion cells (RGC), according to a study published in the scientific journal Molecular Vision.
January 4, 2017 News by Joana Fernandes, PhD Top 10 Multiple Sclerosis Articles of 2016 A number ofĀ important discoveries, therapeutic developments, and events related to multiple sclerosis (MS) were reported dailyĀ by Multiple Sclerosis News Today throughout 2016. Now that the year is over, it is time to briefly review the articles that appealed most toĀ ourĀ readers. Here are the top 10 most-read articles of 2016, with…
November 14, 2016 News by Patricia Silva, PhD Availability of MS Therapies Provides ‘Peace of Mind’ Value to Society, Study Finds Chronic diseases like multiple sclerosis (MS) not only impact patients, they also inspire fear among healthy people who may be at risk of the disease. In a new study, researchers found that the availability of multiple sclerosis (MS) therapies provides āpeace of mindā value to currently healthy individuals, particularly when…
November 8, 2016 News by Patricia Silva, PhD Plans by 4 Countries to Subsidize Cost of Newer MS Drugs May Weight on US A cost-effectiveness analysis of reimbursement recommendationsĀ for four relatively new multiple sclerosis (MS) treatments made by agencies in four countries ā Australia, Canada, Sweden, and the U.K. ā found overwhelming support (88 percent) for either full or restricted reimbursement for each therapy. The analysis, performed by theĀ Decision Resources Group, is…
October 3, 2016 News by Patricia Silva, PhD Phase 3 Study to Test Oral Combination, Tecfidera and Ponesimod, to Treat Relapsing MS ActelionĀ announced that it will investigate the therapeutic potential of a new, oral combination therapy with ponesimod andĀ Tecfidera (dimethyl fumarate) asĀ a treatment for relapsing multiple sclerosis (RMS). The Phase 3 clinical study, being conducted underĀ a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), aims to find…
September 27, 2016 News by Patricia Silva, PhD How Tecfidera Works to Reduce MS Relapses Finally Discovered, May Lead to Better Treatments How the multiple sclerosis (MS) therapyĀ Tecfidera (dimethyl fumarate) works on a molecular levelĀ hasĀ finally beenĀ uncovered,Ā using a new method that can map a drugās protein targets. The insights gainedĀ may open up new avenues for the development of more specific drugs, based on the same mechanisms, but with fewer side effects. The study,…
September 12, 2016 News by Patricia Silva, PhD #ECTRIMS2016 – Biogen to Unveil Study into Economic and Human Costs of MS At theĀ European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 Congress, taking placeĀ inĀ London on Sept. 14ā17, Biogen will present the Multiple Sclerosis Cost of Illness study, based on research intoĀ more than 16,000 MS patients throughout Europe. The study builds on data from a leading 2005 study that…
August 12, 2016 News by Patricia Inacio, PhD Researchers Reveal Mechanism of Action for Tecfidera, an MS Therapy Researchers found the molecular target of the multiple sclerosis (MS)-approved drug Tecfidera, (dimethyl fumarate or DMF), unveiling the mechanism associated with the drug’s anti-inflammatory action. The study, āDimethyl fumarate blocks pro-inflammatory cytokine production via inhibition of TLR induced M1 and K63 ubiquitin chain formation,ā was…
July 15, 2016 Columns by admin Patients Need To Know What Drugs Do Inside Our Bodies Oral therapy Tecfidera (dimethyl fumarate) seems to be emerging as a first-line treatment for relapsing multiple sclerosis ā according to Biogen, the company that developed it. Thatās good news, and something we need to know. The company agrees that for some time, the long-term effectiveness and safety of this oral…
July 6, 2016 News by InĆŖs Martins, PhD ICER Draft Report Evaluating Therapies for RRMS Now Open for Public Comment TheĀ Institute of Clinical and Economic Review (ICER)Ā released the early draft of a paper intended toĀ informĀ a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called aĀ draft scopingĀ document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and…
July 5, 2016 News by Katie McCallum Latest Findings on RRMS Oral Therapy Tecfidera (Dimethyl Fumarate) Detailed in New Report Since its approval by the U.S. Food and Drug Administration (FDA) in 2013,Ā TecfideraĀ (dimethyl fumarate) has emerged as a first-line treatment for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). While two separate clinical trials demonstrated Tecfidera’s ability to significantly reduce both the rate of relapse…
May 13, 2016 News by admin Dimethyl Fumarate, a Common MS Drug, Found to Work Independently of Nrf2 Pathway AĀ commonly prescribed multiple sclerosis (MS) medication may act to modulate the immune system. The finding is describedĀ in the articleĀ “Dimethyl fumarate treatment induces adaptive and innate immune modulation independent of Nrf2,“Ā published in Ā the journalĀ Proceedings of the National Academy of Sciences. MS develops due to an…
April 20, 2016 News by admin Biogen Releases New Data Showing Effectiveness of Tecfidera in Newly Diagnosed MS Patients at AAN 2016 BiogenĀ reported new data describing the effectiveness of TecfideraĀ (dimethyl fumarate) in newly diagnosed relapsing-remitting multiple sclerosis (RRMS) patients in a recent presentation at the 68th annual meeting of the American Academy of Neurology (AAN). The conference, taking placeĀ in Vancouver, Canada, runs through April 21. Tecfidera is an…