Plegridy (peginterferon beta-1a) - For the treatment of patients with relapsing forms of multiple sclerosis Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Plegridy (peginterferon beta-1a) prefilled syringe and Plegridy Pen (peginterferon beta-1a) prefilled pen Company: Biogen Idec, Inc. Application No.: 125499 Approval Date: 8/15/2014 Persons with disabilities having problems accessing the PDF files

Multiple sclerosis in adults: management Multiple sclerosis in adults: management Multiple sclerosis in adults: management Clinical guideline Published: 8 October 2014 nice.org.uk/guidance/cg186 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available (...) be inconsistent with complying with those duties. Commissioners and providers have 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. Multiple sclerosis in adults: management (CG186) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 28Contents Contents Overview 4 Who is it for? 4

Assessment and management of psychiatric disorders in individuals with multiple sclerosis Evidence-based guideline: Assessment and management of psychiatric disorders in individuals with MS | Neurology Advertisement Search for this keyword Main menu User menu Search Search for this keyword The most widely read and highly cited peer-reviewed neurology journal Share January 14, 2014 ; 82 (2) Special Article Evidence-based guideline: Assessment and management of psychiatric disorders (...) Israel Deaconess Medical Center (P.N.), Harvard Medical School, Boston, MA; Department of Psychiatry (A.F.), University of Toronto, Canada; National Multiple Sclerosis Society (R.C.K.), New York; Mellen Center (D.M.), Cleveland Clinic, OH; Department of Preventive Medicine (D.C.M.), Northwestern University, Evanston, IL; Department of Community Health Sciences & Hotchkiss Brain Institute (S.B.P.), University of Calgary, Canada; VA Maryland Health Care System (C.B.), Baltimore, MD; Santa Fe, NM (R.B.S

Complementary and alternative medicine in multiple sclerosis Summary of evidence-based guideline: Complementary and alternative medicine in multiple sclerosis | Neurology Advertisement Search for this keyword Main menu User menu Search Search for this keyword The most widely read and highly cited peer-reviewed neurology journal Share March 25, 2014 ; 82 (12) Special Article Summary of evidence-based guideline: Complementary and alternative medicine in multiple sclerosis Report of the Guideline (...) , Portland; MS Center of Excellence–East (C.B.), VA Maryland Health Care System and Department of Neurology (C.B.), University of Maryland School of Medicine, Baltimore; Multiple Sclerosis Center (J.B.), Swedish Neuroscience Institute, Seattle, WA; Multiple Sclerosis Service and Complementary and Alternative Medicine Service (A.B.), Colorado Neurological Institute, Englewood; The Jacobs Neurological Institute (B.W.-G.), Buffalo, NY; Department of Neurology (G.S.G.), University of Kansas Medical Center

Teriflunomide for treating relapsingûremitting multiple sclerosis (TA303) Overview | Teriflunomide for treating relapsing–remitting multiple sclerosis | Guidance | NICE Teriflunomide for treating relapsing–remitting multiple sclerosis Technology appraisal guidance [TA303] Published date: 22 January 2014 Last updated: 01 June 2014 Share Guidance on teriflunomide (Aubagio) for treating relapsing–remitting multiple sclerosis in adults. Guidance development process Next review : When the review

Alemtuzumab for treating relapsing-remitting multiple sclerosis (TA312) Overview | Alemtuzumab for treating relapsing‑remitting multiple sclerosis | Guidance | NICE Alemtuzumab for treating relapsing‑remitting multiple sclerosis Technology appraisal guidance [TA312] Published date: 28 May 2014 Share Guidance on alemtuzumab (Lemtrada) for treating relapsing–remitting multiple sclerosis in adults. Guidance development process Next review: We will decide whether to review this guidance when

Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial. Secondary progressive multiple sclerosis, for which no satisfactory treatment presently exists, accounts for most of the disability in patients with multiple sclerosis. Simvastatin, which is widely used for treatment of vascular disease, with its excellent safety profile, has immunomodulatory and neuroprotective properties (...) that could make it an appealing candidate drug for patients with secondary progressive multiple sclerosis.We undertook a double-blind, controlled trial between Jan 28, 2008, and Nov 4, 2011, at three neuroscience centres in the UK. Patients aged 18-65 years with secondary progressive multiple sclerosis were randomly assigned (1:1), by a centralised web-based service with a block size of eight, to receive either 80 mg of simvastatin or placebo. Patients, treating physicians, and outcome assessors were

Pharmacoeconomic review report. Teriflunomide (Aubagio ? Genzyme Canada) indication: relapsing-remitting multiple sclerosis Pharmacoeconomic review report. Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis Pharmacoeconomic review report. Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA (...) . No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH. Pharmacoeconomic review report. Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Pharmacoeconomic Review Report; SR0350. 2014 Authors' conclusions CDR found several limitations with the manufacturer's economic analysis. A reanalysis addressing all of these limitations (except treatment waning

Clinical review report. Teriflunomide (Aubagio ? Genzyme Canada) indication: relapsing-remitting multiple sclerosis Clinical review report. Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis Clinical review report. Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality (...) of this assessment has been made for the HTA database. Citation CADTH. Clinical review report. Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Clinical Review Report; SR0350. 2014 Authors' conclusions Based on the results of two phase 3 double-blind randomized controlled trials, teriflunomide 14 mg may reduce the annualized relapse rate (ARR) by approximately 30% to 35% compared

Teriflunomide (Aubagio ? Genzyme Canada) indication: relapsing-remitting multiple sclerosis Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH (...) . Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDEC Final Recommendation; SR0350. 2014 Authors' conclusions The Canadian Drug Expert Committee (CDEC) recommends that teriflunomide not be listed at the submitted price. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Administration, Oral; Canada; Crotonates; Drug Evaluation; Immunologic Factors; Multiple Sclerosis

Daclizumab for relapsing remitting multiple sclerosis. Monoclonal antibodies such as daclizumab could be a possible alternative immunotherapy to interferon beta treatment in people with multiple sclerosis (MS). It blocks the interleukin-2 receptor alpha subunit (CD25), and seems to be beneficial to patients with relapsing remitting multiple sclerosis (RRMS) in clinical and magnetic resonance imaging (MRI) measures of outcomes.This is an update of a Cochrane review first published in 2010 (...) , and previously updated in 2012.To assess the safety of daclizumab and its efficacy to prevent clinical worsening in patients with RRMS.The Trials Search Co-ordinator searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register (17 May 2013). We handsearched the references quoted in the identified trials and reports (May 2013) from the most important neurological associations and MS societies. We contacted researchers participating in trials

Rituximab for relapsing-remitting multiple sclerosis. This is an update of the Cochrane review "Rituximab for relapsing-remitting multiple sclerosis" (first published in The Cochrane Library 2011, Issue 12).More than 80% of individuals with multiple sclerosis (MS) experience a relapsing-remitting disease course. Approximately 10 years after disease onset, an estimated 50% of individuals with relapsing-remitting MS (RRMS) convert to secondary progressive MS. MS causes a major socioeconomic (...) Trials Search Co-ordinator searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register (9 August 2013). We checked the references in identified trials and manually searched the reports (2004 to August 2013) from neurological associations and MS societies in Europe and America. We also communicated with researchers who were participating in trials on rituximab and contacted Genentech, BiogenIdec and Roche.All randomised, double-blind, controlled

A systematic review of randomized, double-blind, placebo-controlled trials examining the clinical efficacy of vitamin D in multiple sclerosis A systematic review of randomized, double-blind, placebo-controlled trials examining the clinical efficacy of vitamin D in multiple sclerosis A systematic review of randomized, double-blind, placebo-controlled trials examining the clinical efficacy of vitamin D in multiple sclerosis Pozuelo-Moyano B, Benito-Leon J, Mitchell AJ, Hernandez-Gallego J CRD (...) summary The authors' cautious conclusion that there was a lack of evidence to support vitamin D as a treatment for multiple sclerosis, can be considered to be reliable. Authors' objectives To review the evidence for vitamin D in the treatment of multiple sclerosis. Searching PubMed and Cochrane Central Register of Controlled Trials (CENTRAL) were searched to August 2012. Keywords were reported. Personal files, reference lists, and reviews of vitamin D supplementation were searched. No language

Prevalence of extracranial venous narrowing on catheter venography in people with multiple sclerosis, their siblings, and unrelated healthy controls: a blinded, case-control study. Chronic cerebrospinal venous insufficiency has been proposed as a unique combination of extracranial venous blockages and haemodynamic flow abnormalities that occurs only in patients with multiple sclerosis and not in healthy people. Initial reports indicated that all patients with multiple sclerosis had chronic (...) cerebrospinal venous insufficiency. We aimed to establish the prevalence of venous narrowing in people with multiple sclerosis, unaffected full siblings, and unrelated healthy volunteers.We did an assessor-blinded, case-control, multicentre study of people with multiple sclerosis, unaffected siblings, and unrelated healthy volunteers. We enrolled the study participants between January, 2011 and March, 2012, and they comprised 177 adults: 79 with multiple sclerosis, 55 siblings, and 43 unrelated controls

Cell therapy for multiple sclerosis: an evolving concept with implications for other neurodegenerative diseases. Multiple sclerosis is a major cause of neurological disability, and particularly occurs in young adults. It is characterised by conspicuous patches of damage throughout the brain and spinal cord, with loss of myelin and myelinating cells (oligodendrocytes), and damage to neurons and axons. Multiple sclerosis is incurable, but stem-cell therapy might offer valuable therapeutic (...) potential. Efforts to develop stem-cell therapies for multiple sclerosis have been conventionally built on the principle of direct implantation of cells to replace oligodendrocytes, and therefore to regenerate myelin. Recent progress in understanding of disease processes in multiple sclerosis include observations that spontaneous myelin repair is far more widespread and successful than was previously believed, that loss of axons and neurons is more closely associated with progressive disability than

Botulinum toxin type a (Botox) - Management of urinary incontinence in adult patients with neurogenic detrusor overactivity due to subcervical spinal cord injury (traumatic or non-traumatic) or multiple sclerosis Published 07 October 2013 botulinum toxin type A 50, 100, 200 Allergan units/vial (Botox ® ) SMC No. (916/13) Allergan Ltd 06 September 2013 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 Scotland. The advice is summarised as follows: ADVICE: following a full submission botulinum toxin type A (Botox ® ) is accepted for use within NHS Scotland. Indication under review: Management of urinary incontinence in adult patients with neurogenic detrusor overactivity due to subcervical spinal cord injury (traumatic or non- traumatic) or multiple sclerosis, who are not adequately managed with anticholinergics; patients should be already catheterising or willing

Dimethyl fumarate - Multiple Sclerosis, relapsing Common Drug Review CDEC Meeting – July 17, 2013; CDEC Reconsideration – September 18, 2013 Notice of CDEC Final Recommendation – September 25, 2013 Page 1 of 5 © 2013 CADTH CDEC FINAL RECOMMENDATION DIMETHYL FUMARATE (Tecfidera — Biogen Idec Canada Inc.) Indication: Relapsing-Remitting Multiple Sclerosis Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that dimethyl fumarate be listed for the treatment of relapsing-remitting (...) multiple sclerosis (RRMS) if both the clinical criterion and the condition are met: Clinical Criterion: ? Patients who have a contraindication to, or who have failed to respond to adequate courses of both of the following: at least one interferon beta-1b formulation and glatiramer acetate. Condition: ? The patient is under the care of a neurologist who is experienced in the diagnosis and management of multiple sclerosis (MS). Reasons for the Recommendation: 1. Two placebo-controlled, randomized

[Efficacy and safety of the immunoregulatory drugs interferon beta and glatiramer in the treatment of relapsing remitting multiple sclerosis] Eficacia y seguridad de los fármacos inmunoreguladores, interferón beta y glatiramero, en la esclerosis múltiple remitente recidivante [Efficacy and safety of the immunoregulatory drugs interferon beta and glatiramer in the treatment of relapsing remitting multiple sclerosis] Eficacia y seguridad de los fármacos inmunoreguladores, interferón beta y (...) glatiramero, en la esclerosis múltiple remitente recidivante [Efficacy and safety of the immunoregulatory drugs interferon beta and glatiramer in the treatment of relapsing remitting multiple sclerosis] Martínez Férez IM, Flores Moreno S, Rodríguez López R Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Martínez Férez IM, Flores Moreno S, Rodríguez

A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis Fatigue is a common and troubling symptom for people with multiple sclerosis (MS).To evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (...) (FACETS)).Three-centre parallel arm randomised controlled trial with economic evaluation. Patients with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis-Fatigue Self-Efficacy) and disease-specific quality of life (Multiple

Laquinimod for multiple sclerosis. Multiple sclerosis (MS) is a chronic immune-mediated, inflammatory, demyelinating, neurodegenerative disorder of the central nervous system, and it causes major socioeconomic burden for the individual patient and for society. An inflammatory pathology occurs during the early relapsing stage of MS and a neurodegenerative pathology dominates the later progressive stage of the disease. Not all MS patients respond adequately to currently available disease (...) therapy versus placebo or approved DMDs (interferon-β, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, teriflunomide, dimethyl fumarate) for modifying the disease course in patients with MS.The Review Group Trials Search Co-ordinator searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register which, among other sources, contains trials from CENTRAL (The Cochrane Library 2013, Issue 2), MEDLINE, EMBASE, CINAHL, LILACS, PEDro