October 16, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Study Examines Relapses When Stopping Gilenya During, After Pregnancy Up to half of women with multiple sclerosis (MS) who stop treatment with Gilenya (fingolimod) when planning to become pregnant will experience a relapse during pregnancy, according to a new study. The findings also revealed relapses over the first six months after giving birth in a quarter of…
October 15, 2018 News by BioNews Staff #ECTRIMS2018 ā As Siponimod Awaits FDA Decision, Mouse Work Helps in Understanding Benefits Seen in SPMS Mouse studies ofĀ siponimod ā a potential progressive multiple sclerosis (MS) treatment that’s up for approval in the U.S. and EU ā were among presentations given by NovartisĀ at the 34th European Committee for Treatment and Research in Multiple SclerosisĀ (ECTRIMS), held Oct. 10-12 in Berlin. Animal work might seem…
October 15, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Plasma Neurofilament Light Levels Linked to Treatment Effects in RRMS, Study Finds Levels of proposed biomarker neurofilament light chain (NfL) are associated with therapeutic effects of disease-modifying treatments (DMTs) inĀ relapsing-remitting multiple sclerosisĀ (RRMS) patients, according to a real-world study. Study findings also revealed that treatment with either Lemtrada (alemtuzumab, marketed byĀ Sanofi Genzyme),Ā Gilenya (fingolimod, marketed by Novartis), Tecfidera (dimethyl fumarate, marketed…
October 10, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Switching to Tysabri Leads to Fewer Relapses and Disability than Gilenya, Study in RRMS Patients Finds Patients with relapsing-remitting multiple sclerosis (RRMS) who switch to Tysabri (natalizumab) after relapses on first-line treatment with other medications show greater relapse reduction and less disability progression than those switching to Gilenya (fingolimod), according to a real-world study. The research, āComparative effectiveness of switching…
October 10, 2018 News by Alice MelĆ£o, MSc FDA, EMA Agree to Review Novartis Therapy Siponimod to Treat SPMS Novartis is seeking U.S. and European approval of its investigational oral agent siponimodĀ to treat adults with secondary progressive multiple sclerosis (SPMS). The U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application, while the European Medicines Agency (EMA) has accepted for review…
October 4, 2018 News by BioNews Staff #ECTRIMS2018 – Emerging MS Treatments, from Cannabinoids to Diet, Among Highlights at Conference Thousands of scientists, doctors, pharmaceutical company executives and others ā representing about 100 countries ā will meet for three days to discuss and debate the latest developments in multiple sclerosis (MS) at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, best known as…
September 24, 2018 News by Jose Marques Lopes, PhD CHMP Favors Approving Gilenya to Treat Children and Teenagers with RRMS in Europe The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended thatĀ Gilenya (fingolimod) be approved to treat children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS). If the CHMP opinion is accepted, Gilenya ā marketed by…
September 21, 2018 News by Alice MelĆ£o, MSc Ocrevus Climbing as First-line DMT for RRMS Among Neurologists Surveyed in Spherix Report Eighteen months after its entrance into the U.S. market,Ā Genentechās Ocrevus (ocrelizumab) has become the monoclonal antibody of choice to treat patients with multiple sclerosis (MS), according to a survey of nearly 100 neurologists across the U.S. Self-reported use of Ocrevus for theĀ third quarter of 2018 surpassed…
September 17, 2018 News by Patricia Inacio, PhD Gilenya More Effective Than Avonex in Lowering Relapse Rates, New Lesions in Children with Relapsing MS, Phase 3 Trial Shows Two years of treatment with oral GilenyaĀ (fingolimod) significantly reduced the rate of relapses when compared toĀ AvonexĀ (interferon beta-1a) intramuscular injections in children and adolescents with relapsing forms of multiple sclerosis (RMS), according to Phase 3 clinical trial results. Additionally, Gilenya (marketed by Novartis) decreased the number of central nervous…
August 30, 2018 News by Marta Figueiredo, PhD Tecfidera, Gilenya Equally Effective, But More MS Patients Stop Tecfidera, Real-World Study Shows TecfideraĀ (dimethyl fumarate) and GilenyaĀ (fingolimod) are equally effective in treating multiple sclerosis (MS),Ā but Tecfidera shows higher rates of discontinuation, according to a real-world study. The study, āDiscontinuation and comparative effectiveness of dimethyl fumarate and fingolimod in 2 centers,ā was published in the journal Neurology Clinical…
August 23, 2018 News by Stacy Grieve, PhD Case Study Suggests Need for New Treatment Strategy When Switching from Gilenya to Rituximab Discontinuing Gilenya (fingolimod) treatment and starting on rituximab therapy may be more complicated than originally thought. A new report chronicles the medical journey of a man with multiple sclerosis (MS) treated with these drugs, and proposes a new treatment regimen. Both Gilenya (an approved MS therapy marketed by…
August 21, 2018 News by Janet Stewart, MSc Consecutive Use of Gilenya and Lemtrada Causes Disease Activity in MS Patient, Case Report Suggests Multiple sclerosis (MS) patients may experience severe disease exacerbation after switching fromĀ NovartisāĀ Gilenya (fingolimod) to Sanofi Genzymeās LemtradaĀ (alemtuzumab), a case report suggests. This unexpected high disease activity raises questions about managing MS through the consecutive use of immunotherapies. The case report, āUnexpected high multiple…
July 30, 2018 News by Jose Marques Lopes, PhD African-Americans Show Better Adherence and Satisfaction with Gilenya Than Injectable DMTs, Phase 4 Study Finds African-Americans with relapsingāremitting multiple sclerosis (RRMS) show higher adherence and greater satisfaction when treated with oralĀ Gilenya (fingolimod, by Novartis) than with injectable therapies, according to a new study. The research, āTreatment retention on fingolimod compared with injectable multiple sclerosis therapies in African-American patients: A…
July 23, 2018 News by Ana Pena PhD Shorter Washout Period Lessens Relapse Risk When Switching from Tysabri to Gilenya in RRMS, Study Finds Shortening the washout period to four weeks when switching from Biogenās Tysabri to Novartisā Gilenya is safe and reduces the chances of experiencing a disease flare in patients with relapsing-remitting multiple sclerosis (RRMS), a small Swiss study found. A four-week washout reduced the risk of having a disease relapse or an increase in disease activity, compared with an eight-week washout period, for two years after switching from Tysabri to Gilenya. Although TysabriĀ effectively slows worsening of MS symptoms and the appearance of disease flares, its use is under a strict risk management plan as it heightens the risk of developing a rare and life-threatening brain infection called progressive multifocal leukoencephalopathy, also known as PML. Some patients may switch to Gilenya, an alternative disease-modifying therapy for RRMS. Gilenya has been associated with a lower risk of PML infection and seen to reduce relapses, disability worsening, and the appearance of new brain lesions on clinical trials. It also is the only therapy approved by the U.S. Food and Drug Administration for children with MS as young as 10. When switching from Tysabri to Gilenya, it is important to consider the washout period, which is the period when the patient is taken off medications. If too long, it may lead to disease reactivation, which can be even stronger than before starting Tysabri. There is little evidence about the optimal length of washout periods, but a Phase 3 trial showed that an eight-week washout between Tysabri and Gilenya was beneficial compared with longer washouts of 12 or 16 weeks. The eight-week washout enabled more RRMS patients to become free from relapses and lowered disease activity. To study if a shorter washout period of four weeks further reduced the risk of MS reactivation, researchers conducted an open-label, observational study at the University Hospital, Basel, Switzerland. The study enrolled 25 RRMS patients who were appointed to switch from Tysabri to Gilenya. Participants were assigned to either a four-week or an eight-week washout period, and were followed for two years after switching to Gilenya. Although patients were older in the four-week washout group, disease activity and disability scoreswere not significantly different between groups at the beginning of the study. Relapses, disability scores, and disease activity on magnetic resonance imaging scans were recorded at baseline and weeks 8, 12, 16, 20 32, 56, and 108. In the first year (week 56) the proportion of patients with disease flare-ups or disease activity on MRI was not significantly different between the two washout groups, affecting 55.6% and 62.5% of the patients who had a four-week and an eight-week washout, respectively. However, at the end of the two-year follow-up (week 108), recurrent event analysis showed that patients who were on the four-week washout group were 77% less likely to experience relapses. The combined risk for relapse or disease activity on MRI also was 58% lower in the four-week group,Ā compared with those who had an eight-week washout. In addition, researchers found that patients who had flares more frequently in the year before discontinuing Tysabri also had a nearly four times higher risk of experiencing relapses in the first year after switching to Gilenya. ThisĀ suggests that the number of relapses before switching from Tysabri can predict disease reactivation once on other disease-modifying therapies. Both washout periods were deemed safe, with no serious adverse side effects or cases of opportunistic infections, including PML, being reported. Researchers emphasized, however, that the findings need to be confirmed in larger studies.
July 10, 2018 News by Iqra Mumal, MSc RRMS Patients Show High Levels of Satisfaction and Adherence to Gilenya Over 2 Years in Danish Study People with relapsing-remitting multiple sclerosis in Denmark show high rates of adherence to treatment with Gilenya (fingolimod), and give the therapy high marks in terms of satisfaction and quality of life, a long-term study of its use by RRMS patients reports. The study, āHigh treatment adherence, satisfaction, motivation,…
June 27, 2018 News by Patricia Inacio, PhD After Ocrevus Approval, New Therapies May Become Available for MS, Report Suggests Genentech‘s OcrevusĀ (ocrelizumab),Ā approved in March 2017, has fueled a sea change in the treatment of multiple sclerosis (MS) patients in the U.S., leading to an increased interest in disease-modifying therapies (DMTs) for progressive forms of MS. Now, other potential treatment choices for progressive MS forms will likely…
June 20, 2018 News by Patricia Inacio, PhD #EAN2018 – Levels ofĀ Neurofilament Light Chain Can Predict Disease Progression in RRMS, Study Shows Levels ofĀ neurofilament light chain are a reliable predictor of disease worsening and progression in relapsing-remitting MS (RRMS) patients, a new study shows. Moreover, treatment withĀ GilenyaĀ (fingolimod), marketed by Novartis, can reduce the levels ofĀ NfL for up to 10 years. These findings were shared recently in the presentation ā…
June 13, 2018 News by Vijaya Iyer, PhD Effectiveness of Gilenya and Tecfidera Compared in Real-World Study in Italy Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are equally effective as first-line treatments in people with relapsing-remittingĀ multiple sclerosis (RRMS), but Gilenya may be of slightly more benefit to those who switch from a previous injectable therapy, according to a real-world study of patients in Italy. The study, “…
June 12, 2018 News by Vijaya Iyer, PhD Gilenya Seen to Particularly Benefit Young Adults with Higher Relapse Rates, Trial Data Show Young adults withĀ multiple sclerosis (MS) have higher relapse rates and respond better to Gilenya treatment compared to the overall MS population, data from a post hoc analysis of three separate trials show. The study, āRelapse Rate and MRI Activity in Young Adult Patients With Multiple…
May 29, 2018 Columns by Ed Tobias Pressure in the UK Helps Lower MS Therapy Costs. But What About the US? In the United States, the government can do very little to control the costs of our expensive MS medications. In the United Kingdom, it’s a different story. The U.K. has an organization called the National Institute for Health and Care Excellence, better known as NICE. NICE provides healthcare…
May 24, 2018 News by Ashraf Malhas, PhD Gilenya Tied to Treatment Satisfaction, Quality of Life in MS Patients Treatment with Gilenya (fingolimod) is associated with treatment satisfaction, which, in turn, is linked to a better quality-of-life in patients withĀ relapsing-remitting multiple sclerosis (RRMS), a study has found. Gilenya, an oral disease-modifying treatment (DMT) for RRMS developed by Novartis, has been available in France since 2011. Studies have…
May 21, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: PML Treatment, Gilenya for Kids, Rituximab, and an MS trial that is Enrolling Complications from Gilenya Treatment Managed Successfully, Case Report Says This wasn’t a minor complication. It was a version of PML, a brain disease that can be fatal. PML is also a known side effect of Tysabri, so the report of a successful treatment should be important to…
May 18, 2018 Columns by Ed Tobias A Pediatric MS Medication Gets the OK Until about a week ago, no medication was approved in the U.S. to treat patients with pediatric-onset MS (POMS). Now there is one. The Food and Drug Administration (FDA) has given its OK to use Gilenya (fingolimod) to treat relapsing MS in children and adolescents starting at…
May 16, 2018 News by Janet Stewart, MSc Complications from Gilenya Treatment Managed Successfully, Case Report Says A case study reported the successful management of a multiple sclerosis (MS) patient who developed a rare condition in the brain ā progressive multifocal leukoencephalopathyĀ (PML) ā due to treatment with Novartis Pharmaceuticalās Gilenya (fingolimod). The study, titled āFingolimod-associated PML with mild IRIS in MS: A…
May 16, 2018 News by Patricia Silva, PhD 4 Relapsing MS Treatments Added to UK Health Service After Cuts to Prices Agreed After an agreement to lower their prices, four treatments for relapsing multiple sclerosis āĀ Biogenās AvonexĀ and Merck KGaA‘sĀ Rebif (both interferon beta-1a), Novartisā ExtaviaĀ (interferon beta 1b), and Tevaās Copaxone (glatiramer acetate) ā were recommended as cost-effective and long-term therapy options within the National Health Service…
May 15, 2018 News by Alice MelĆ£o, MSc Gilenya Approved by FDA as First DMT for Children, Ages 10 and Older, with Relapsing MS Gilenya (fingolimod) has become the first disease-modifying therapy approved by the U.S. Food and Drug Administration (FDA) to treat children and adolescents with relapsing forms of multiple sclerosis (MS). This expanded approval allows Gilenya, previously indicated for adults patients 18 or older, to be used to treat pediatric relapsing MS…
May 9, 2018 Columns by Cathy Chester The Agony of Decision-making when It’s Time to Switch MS Medications Iām agonizing over an important decision and it’s driving me crazy. Iām usually a quick decision-maker, but this one is tough. I have my analytical hat on, trying to look at my choices from a scientific standpoint. Unfortunately, my anxiety kicks in, and my hat…
May 1, 2018 Columns by Ed Tobias Is This a Step Toward Lower Medication Prices? Here in the U.S., the price we pay for medications is complicated. The usual process is for a pharmaceutical company to set a high price for a medication when it first hits the market. But, like buying a car, that “sticker” price is negotiable. Health plans use pharmaceutical benefit…
April 30, 2018 Columns by Ed Tobias MS News that Caught My Eye This Week: aHSCT Studies, MS Progression in African-Americans, Gilenya for Pediatrics #AAN2018 ā Stem Cell Transplant is Effective Treatment for āAggressiveā MS, Study Shows I like the fact that a study shows that stem cell transplant treatment is effective for aggressive MS. I love the fact that the efficacy was dramatic, reducing theĀ Expanded Disability Status Scale (EDSS) levels…
April 27, 2018 News by Jose Marques Lopes, PhD #AAN2018 – Siponimod Lessens Risk of SPMS Progression Independent of Relapses, Trial Data Show Novartisā investigational oral treatmentĀ siponimod (BAF312) reduces the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS), a new analysis of Phase 3 trial results show. Using what the company describes as more accurate methods to assess siponimod effect’s on progression risk, necessary because the…