Ozanimod (supplied as ozanimod hydrochloride) - Zeposia - relapsing remitting multiple sclerosis Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs

Siponimod for treating secondary progressive multiple sclerosis Siponimod for treating secondary progressive multiple sclerosis T echnology appraisal guidance Published: 18 November 2020 www.nice.org.uk/guidance/ta656 © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Your responsibility Your responsibility The recommendations in this guidance represent the view of NICE, arrived at after careful consideration (...) to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Siponimod for treating secondary progressive multiple sclerosis (TA656) © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 20Contents Contents 1 Recommendations 4 2 Information about siponimod 5 Marketing authorisation indication 5 Dosage

Siponimod (multiple sclerosis) - Addendum to Commission A20-10 1 Translation of addendum A20-51 Siponimod (multiple Sklerose) – Addendum zum Auftrag A20-10 (Version 1.0; Status: 16 July 2020). Please note: This translation is provided as a service by IQWiG to English- language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 16 July 2020 1.0 Commission: A20-51 Version: Status: IQWiG Reports – Commission No. A20-51 Siponimod (multiple (...) sclerosis) – Addendum to Commission A20-10 1 Addendum A20-51 Version 1.0 Siponimod – Addendum to Commission A20-10 16 July 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Siponimod (multiple sclerosis) – Addendum to Commission A20-10 Commissioning agency Federal Joint Committee Commission awarded on 23 June 2020 Internal Commission No. A20-51 Address of publisher Institut für Qualität und

Siponimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Siponimod (multiple Sklerose) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A20-10 Siponimod (...) (multiple sclerosis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A20-10 Version 1.0 Siponimod (multiple sclerosis) 13 May 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Siponimod (multiple sclerosis) – Benefit assessment according to §35a Social Code Book V Commissioning agency Federal Joint Committee Commission awarded on 5 February 2020 Internal

Siponimod (Mayzent) - secondary progressive multiple sclerosis (SPMS) 1 Published 12 October 2020 1 SMC2265 siponimod 250 microgram and 2mg film-coated tablets (Mayzent®) Novartis Pharmaceuticals UK Ltd 04 September 2020 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission siponimod (...) (Mayzent®) is accepted for use within NHSScotland. Indication under review: treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. In a randomised, double-blind, placebo-controlled phase III study, siponimod was associated with a reduction in disability progression confirmed after 3 months in patients with SPMS. This advice applies only in the context of an approved NHSScotland Patient

Fampridine - multiple sclerosis (MS) Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. EMA/410661/2020 EMEA/H/C/005359 Fampridine Accord (fampridine) An overview of Fampridine Accord (...) and why it is authorised in the EU What is Fampridine Accord and what is it used for? Fampridine Accord is a medicine used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability. MS is a disease in which the immune system (the body’s defences) attacks and damages the covering around the nerves and the nerves themselves in the brain and spinal cord. Fampridine Accord is a ‘generic medicine’. This means that Fampridine Accord contains the same active substance

Ofatumumab versus Teriflunomide in Multiple Sclerosis. Ofatumumab, a subcutaneous anti-CD20 monoclonal antibody, selectively depletes B cells. Teriflunomide, an oral inhibitor of pyrimidine synthesis, reduces T-cell and B-cell activation. The relative effects of these two drugs in patients with multiple sclerosis are not known.In two double-blind, double-dummy, phase 3 trials, we randomly assigned patients with relapsing multiple sclerosis to receive subcutaneous ofatumumab (20 mg every 4 weeks (...) neurofilament light chain levels, but not the change in brain volume, were in the same direction as the primary end point. Injection-related reactions occurred in 20.2% in the ofatumumab group and in 15.0% in the teriflunomide group (placebo injections). Serious infections occurred in 2.5% and 1.8% of the patients in the respective groups.Among patients with multiple sclerosis, ofatumumab was associated with lower annualized relapse rates than teriflunomide. (Funded by Novartis; ASCLEPIOS I and II

The Effect of Transcranial Direct Current Stimulation on Chronic Neuropathic Pain in Patients with Multiple Sclerosis: Randomized Controlled Trial The Effect of Transcranial Direct Current Stimulation on Chronic Neuropathic Pain in Patients with Multiple Sclerosis: Randomized Controlled Trial - PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features! Clipboard, Search History, and several other advanced features are temporarily (...) on Chronic Neuropathic Pain in Patients with Multiple Sclerosis: Randomized Controlled Trial , , , Affiliations Expand Affiliations 1 Rehabilitation Department, Royal Melbourne Hospital, Royal Park Campus, Melbourne, Australia. 2 Department of Medicine and Radiology, Integrated Critical Care, University of Melbourne, Melbourne, Australia. 3 Department of Rehabilitation, Nutrition and Sport, Discipline of Physiotherapy, School of Allied Health, La Trobe University, Melbourne, Australia. 4 Department

Fingolimod - relapsing-remitting multiple sclerosis (RRMS) Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. EMA/336317/2020 EMEA/H/C/005191 Fingolimod Accord (fingolimod (...) ) An overview of Fingolimod Accord and why it is authorised in the EU What is Fingolimod Accord and what is it used for? Fingolimod Accord is a type of medicine known as a ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (RRMS). ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods with milder or no symptoms (remissions). Fingolimod Accord is used when

EAN guideline on palliative care of people with severe, progressive multiple sclerosis EAN guideline on palliative care of people with severe, progressive multiple sclerosis A. Solari a , A. Giordano a,b , J. Sastre-Garriga c ,S.K€ opke d,e , A. C. Rahn e , I. Kleiter f , K. Aleksovska g , M. A. Battaglia h , J. Bay i , M. Copetti j , J. Drulovic k , L. Kooij l , J. Mens l , E. R. Meza Murillo c , I. Milanov m , R. Milo n,o , T. Pekmezovic p , J. Vosburgh q , E. Silber r , S. Veronese s , F (...) . Patti t , R. Voltz u,v , D. Oliver w and on behalf of the guideline task force , * a Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan; b Department of Psychology, University of Turin, Turin, Italy; c Department of Neurology/Neuroimmunology, Multiple Sclerosis Centre of Catalonia (Cemcat), Hospital Universitari Vall d’Hebron, Universitat Aut onoma de Barcelona, Barcelona, Spain; d Institute of Clinical Nursing Science, University of Cologne, Cologne; e Institute

Ozanimod (Zeposia) - relapsing-remitting multiple sclerosis (RRMS) Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. EMA/171870/2020 EMEA/H/C/004835 Zeposia (ozanimod) An overview (...) of Zeposia and why it is authorised in the EU What is Zeposia and what is it used for? Zeposia is a medicine used to treat adults with relapsing-remitting multiple sclerosis (RRMS), where the patient has flare-ups (relapses) followed by periods with milder or no symptoms (remission). It is used in patients with active disease, which means that patients have relapses or signs of active inflammation on scans. Zeposia contains the active substance ozanimod. How is Zeposia used? Zeposia can only be obtained

Amiloride, fluoxetine or riluzole to reduce brain volume loss in secondary progressive multiple sclerosis: the MS-SMART four-arm RCT Amiloride, fluoxetine or riluzole to reduce brain volume loss in secondary progressive multiple sclerosis: the MS-SMART four-arm RCT Journals Library An error occurred retrieving content to display, please try again. >> >> >> Page Not Found Page not found (404) Sorry - the page you requested could not be found. Please choose a page from the navigation or try (...) Stutters 1 , David MacManus 1 , Ferran Prados 1, 4, 5 , Ian Marshall 2 , Bhavana Solanky 1 , Rebecca S Samson 1 , Frederik Barkhof 1, 4, 6 , Sebastien Ourselin 7 , Marie Braisher 1 , Moira Ross 3 , Gina Cranswick 3 , Sue H Pavitt 8 , Sharmilee Gnanapavan 9 , Gavin Giovannoni 9 , Claudia AM Gandini Wheeler-Kingshott 1, 10 , Clive Hawkins 11 , Basil Sharrack 12 , Roger Bastow 13 , Christopher J Weir 3 , Nigel Stallard 14 , Siddharthan Chandran 2 , Jeremy Chataway 1, 15, * 1 Queen Square Multiple

Dietary interventions for multiple sclerosis-related outcomes. Multiple sclerosis (MS) is a common demyelinating disease of the central nervous system. Although the exact pathogenesis remains unknown, the leading theory is that it results from immune system dysregulation. Approved disease-modifying therapy appears to modulate the immune system to improve MS-related outcomes. There is substantial interest in the ability of dietary interventions to influence MS-related outcomes. This is an update (...) of the Cochrane Review 'Dietary interventions for multiple sclerosis' (Farinotti 2003; Farinotti 2007; Farinotti 2012).To assess the effects of dietary interventions (including dietary plans with recommendations for specific whole foods, macronutrients, and natural health products) compared to placebo or another intervention on health outcomes (including MS-related outcomes and serious adverse events) in people with MS.On 30 May 2019, we searched CENTRAL, MEDLINE, Embase, and Web of Science. We also searched

Siponimod (Mayzent) - multiple sclerosis Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012

Ozanimod (Zeposia) - To treat relapsing forms of multiple sclerosis Drug Approval Package: ZEPOSIA U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: ZEPOSIA Company: Celgene Corporation Application Number: 209899 Approval Date: 03/20/2020 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review Files (PDF) (PDF) (PDF) (PDF) (PDF

Fampridine (Fampyra) - For the improvement of walking in adult patients with multiple sclerosis 1 Published 13 April 2020 1 SMC2253 fampridine 10mg prolonged-release tablet (Fampyra®) Biogen Idec Ltd 06 March 2020 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a second resubmission fampridine (Fampyra (...) ® ) is accepted for use within NHSScotland. Indication under review: For the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS [expanded disability status scale] 4-7). In double-blind phase III studies fampridine, compared with placebo, improved walking ability in adults with multiple sclerosis and walking impairment. This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost

Disease modifying drugs for treatment of primary progressive multiple sclerosis: A health technology assessment Disease modifying drugs for treatment of primary progressive multiple sclerosis: A health technology assessment - NIPH Search for: Søk Menu To top level Close Infectious diseases & Vaccines Mental & Physical health Environment & Lifestyle Health in Norway Quality & Knowledge Research & Access to data About NIPH Close Disease modifying drugs for treatment of primary progressive (...) multiple sclerosis: A health technology assessment Order Download: Key message We have systematically collected and reviewed the evidence for clinical efficacy for disease modifying treatments for PPMS. We included three randomised placebo-controlled trials that each compare the effect of one medication (either fingolimod, ocrelizumab or rituximab, respectively) with placebo. For each of the three drugs, we calculated the risk ratios for confirmed disease progression. We also report results in the form

Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis T echnology appraisal guidance Published: 19 February 2020 www.nice.org.uk/guidance/ta624 © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Your responsibility Your responsibility The recommendations in this guidance represent the view of NICE, arrived at after careful (...) a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis (TA624) © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 18Contents Contents 1 Recommendations 4 2 Information about peginterferon beta-1a 5 Marketing

Siponimod (Mayzent) - multiple sclerosis (MS) Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. EMA/629863/2019 EMEA/H/C/004712 Mayzent (siponimod) An overview of Mayzent and why

Siponimod for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity Dec2015 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 1 EUnetHTA Joint Action 3 WP4 Version 1.0, 13/02/2020 Relative effectiveness assessment of pharmaceutical technologies SIPONIMOD FOR THE TREATMENT OF ADULT PATIENTS WITH SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS (...) in the production of this assessment have declared that they have no conflicts of interest in relation to the technology assessed according to the EUnetHTA declaration of interest and confidentiality undertaking form. How to cite this assessment Please cite this assessment as follows: EUnetHTA PTJA08. Authoring Team. Relative effectiveness assessment of pharmaceutical technologies. Siponimod for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced