July 11, 2023 News by Mary Chapman EU project aims to identify best MS treatment for given patient using AI A European Union (EU) initiative is bringing scientists together to develop an artificial intelligence (AI)-based platform that could help in predicting the course of multiple sclerosis (MS) for each person. The consortium’s project, which aims to “offer clinicians a holistic overview of the MS patient” ā from disease…
July 29, 2022 Columns by John Connor What I Didnāt Do on My Forced Summer Holiday Due to the UK Heat Wave No, it wasnāt my good wife, Jane, suddenly insisting we just had to take a break. Spontaneity is no longer a question for me. We can only go somewhere that has both a hoist and a profiling bed. Never mind a Molift and a shower chair. Itās…
September 20, 2021 News by Marisa Wexler, MS Vumerity Recommended for EU Approval as RRMS Treatment A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosisĀ (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…
May 3, 2021 News by Aisha I Abdullah PhD Combining Different Tests Gives Clearer View of Patient Life Quality The combined use of generic and disease-specific health-related quality of life (HRQoL) measures gives a clearer representation of the effects of multiple sclerosis on patients’ quality of life and enables a more accurate comparison across countries, a study has found. āThe…
March 30, 2021 News by Marta Figueiredo, PhD Kesimpta Approved in EU as At-home Injectable Therapy for Relapsing MS The European Commission has approvedĀ Novartisā Kesimpta (ofatumumab) as the first self-administered, at-home B-cell-targeting therapy for adults with relapsing forms ofĀ multiple sclerosis (MS) and active disease. Active disease in these forms, which include clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS),…
February 2, 2021 News by Teresa Carvalho, MS European Project Uses Artificial Intelligence to Help Improve Patient Care The recently launched BRAINTEASER project focuses on the use of artificial intelligence (AI) technology to improve the care of patients with multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). An initiative of a European consortium, BRAINTEASER could benefit patients, caregivers, and clinicians by enhancing the ability to predict,…
December 22, 2020 News by Joana Carvalho, PhD Plegridy as Intramuscular Injection for RRMS Approved in Europe 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 ā in which Plegridy is directly injected into the muscle, rather than under the skin (subcutaneously) ā does…
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…
January 21, 2020 News by Marta Figueiredo, PhD Mayzent Approved in Europe as First Oral Treatment for Active Secondary Progressive MS TheĀ European CommissionĀ has approvedĀ Novartis‘s MayzentĀ (siponimod) as the first oral treatment for adults with active secondary progressive multiple sclerosisĀ (SPMS). Active SPMS is defined by the presence of evident relapses or the detection of inflammatory activity in brain lesions on imaging scans. āAs the only indicated oral therapy proven for…
November 6, 2019 News by Alice MelĆ£o, MSc European 3TR Project Unites Experts in Effort to Make Treatment More Personal and Effective A new public-private initiative brings academic and industry researchers from 15Ā European countries together in a large-scale effort to understand differences and commonalities in seven immune-mediated and inflammatory diseases, including multiple sclerosis, so to better predict a patient’s likely response to treatment and likely disease progression. The project, called 3TR…
October 11, 2019 News by Ana Pena PhD Mavenclad, Ocrevus Use Rising in EU as Injectables and Tysabri Decline, Spherix Reports Prescriptions of two multiple sclerosisĀ (MS) treatments ā Ā Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) ā have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run…
August 21, 2019 News by Ana Pena PhD Gilenya, Aubagio, Tysabri, Tecfidera Dominate MS Therapy Switches in Europe, Spherix Survey Finds Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘sĀ Aubagio (teriflunomide), andĀ BiogenāsĀ TysabriĀ (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…
March 12, 2019 News by Jonathan Grinstein Celgene Seeks Approval in European Union for Ozanimod to Treat Adult RRMS An application has been submitted for the use of ozanimod to treat adult patients withĀ relapsing-remitting multiple sclerosis (RRMS)Ā within the European Union, according toĀ Celgene, the developer of ozanimod. The marketing authorization application was submitted to the European Medicines Agency…
June 20, 2018 News by Alice MelĆ£o, MSc #EAN2018 ā New Guidelines for MS Treatment in Europe Set by EAN, ECTRIMS New treatment guidelines for multiple sclerosis (MS) patients in Europe were set in place through an initiative undertaken by the European Academy of Neurology (EAN) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Launched in parallel to the 4th Congress of the European Academy…
January 15, 2018 News by Patricia Silva, PhD European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU The European Commission has approved Roche’sĀ Ocrevus (ocrelizumab) for both relapsing-remitting multiple sclerosis (RRMS) and primary-progressive multiple sclerosis (PPMS) across the 28-member European Union. The commissionās move ā Ā nearly 10 months after the U.S. Food and Drug Administration (FDA)Ā approvedĀ Ocrevus in March 2017 ā makes it the first approved PPMS…
November 1, 2017 News by Alice MelĆ£o, MSc #MSParis2017 ā MS Places Heavy Burdens on Women, Study in 8 European Countries Shows Multiple sclerosis (MS) can have severe implications on the lives of European women with the disease, finds a new report, affecting their education, their careers and their relationships. This disproportionate burden of MS in women versus men was the focus of a study, āThe Socioeconomic Impact of…
September 29, 2017 News by Patricia Silva, PhD Switzerland First in Europe to Approve Ocrevus for Relapsing and Primary Progressive MS Swiss regulatory authorities approved Ocrevus as a treatment for primary progressive and relapsing forms of multiple sclerosis on Sept. 28, making it the first approval of the drug in a European country. Since Switzerland is not part of the European Union, the approval will not affect the drug's regulatory status in other European countries. So far, the Roche/Genentech drug Ocrevus has been approved in North America, South America, the Middle East, Ukraine, and Australia. Like other countries where Ocrevus has been approved, it's the first drug OK'dĀ in Switzerland for primary progressive MS, a form of the disease where disability moves forward relentlessly. And, as in other countries, the treatment option is equally appreciated among patients with relapsing types of MS. Ocrevus āĀ an antibody that targets B-cells with the surface factor CD20 āĀ was studied in two large Phase 3 trials in patients with relapsing MS called OPERA I and OPERA II (NCT01247324 and NCT01412333). Another trial, called ORATORIO (NCT01194570), is focused on people with primary progressive disease. The trials showed that the treatment significantly reduced disease activity and prevented progression in both patient groups. Researchers compared Ocrevus to Rebif (high-dose interferon beta-1a) in relapsing MS and to a placebo in primary progressive MS. Scientists also consider the drug to have a good safety profile. The most common side effects during the trials were mild-to-moderate infusion reactions and upper respiratory tract infections. Since its approval, researchers also have concluded that the treatment is less expensive than interferon. Ocrevus was approved in the U.S. on March 28, 2017. In the months that followed, many patients were concerned about the trial findings of more cancer cases in the treated, compared to control, groups. Since then, an increased risk of cancer with Ocrevus has not been confirmed, and researchers underscore that it is instead the coincidental and unusual circumstance that there were no cancer cases in the control group that created the imbalance. The European Medicines Agency is still processing the marketing application for Ocrevus. Roche reports that the company has filed marketing applications in more than 50 countries worldwide.
August 29, 2017 News by Patricia Silva, PhD Merckās Mavenclad, an Oral Therapy for Relapsing MS, Approved in European Union The European Commission has approved Merck KGaAās Mavenclad (cladribine tablets)Ā to treatĀ highly active relapsing forms of multiple sclerosis (MS).Ā The Aug. 25 decision in Brussels marks the first approval of a highly efficient oral short course therapy for MS in Europe. Mavenclad has been shown to harness disease activity for…
July 19, 2017 News by Janet Stewart, MSc Costs Associated with Multiple Sclerosis Rise as Severity of Disease Increases, European Study Shows Costs associated with multiple sclerosis increase as the disease worsens, according to a study of more than 16,000 patients in 16 European countries. The study, āNew insights into the burden and costs of multiple sclerosis in Europe,ā was published in the Multiple Sclerosis Journal. Researchers obtained their information from patient self-reporting. Patients used the Kurtzke's Expanded Disability Status Scale (EDSS) to assess the severity of their disease. They also reported on their quality of life and their resource use. Patients were divided into three categories. Those with a score between 0 and 3 on the EDSS scale were deemed to have a mild disease. The disease of those with scores of 4 to 6.5 was considered moderate. And the disease of those with scores of 7 to 9 was classified as severe. Patients assessed their health-related quality of life with the EuroQol Five Dimensions questionnaire. The average age of the 16,808 participants was 51 and a half years old. The work capacity of MS patients dropped from 82 percent of a healthy person's to 8 percent as the severity of the disease increased, researchers said. Patients' quality of life scores were about the same as those seen in the general population when they had a mild disease. But they plunged to less than zero when their disease became severe. The mean annual cost of having a mild form of MS was 22,800 euros, or around $26,300, researchers reported. The cost of having a moderate disease was 37,100 euros, or about $42,800. And the cost of a severe disease was 57,500 euros, or $66,340. Healthcare accounted for 68 percent of total costs with a mild disease, 47 percent with a moderate disease, and 26 percent for a severe disease. "Costs are dependent on the availability, use and price of services and on disease severity," the researchers wrote. "Costs were related to disease severity" in all countries "and were dominated by production losses, non-healthcare costs and DMTs," or disease-modifying therapies. Those therapies may be a key reason why the highest percentage of healthcare costs occurred in patients with a mild disease, researchers said. Doctors prescribe a lot of DMTs to this group. Other factors related to the high percentage were that many patients with mild diseases are still able to work -- meaning they incur fewer production-loss costs -- and this group requires fewer community services. As MS becomes more severe, patients' production losses rise, and they use more community services. "The intensity of healthcare service use varied widely across the countries," researchers wrote. "This reflects differences in healthcare organization, medical traditions, ease of access and ā most importantly ā availability of given services." Researchers also assessed patients' levels of fatigue and cognitive difficulties. Ninety-five percent reported fatigue, and 71 percent cognitive difficulties. Fatigue and cognitive difficulties had significant impacts on quality of life scores, researchers said.
September 9, 2016 News by Patricia Silva, PhD 1st Generic for Copaxone to Treat Relapsing MS Available in Central and Eastern Europe AlvogenĀ recently announced the launch of Remurel (glatiramer acetate) in Central and Eastern Europe, making it the first generic equivalent of Copaxone Ā to be clinically validated for the treatment of relapsing forms of multiple sclerosis (RRMS) in Europe. European health authorities determined that Remurel 20 mg was the therapeutic equivalent…