"Ozanimod"

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                            Ozanimod hydrochloride (Zeposia) Terms of use - Canada.ca * Skip to main content * Skip to "About government" Language selection * Français SearchSearch Canada.ca Search Topics menuMain Menu You are here: 1. Home 2. Health 3. Drug and health products 4. Licensing, authorizing and manufacturing drug and health products 5. Drug and health product review and approval 6. Clinical information on drugs
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                            Ozanimod for treating moderately to severely active ulcerative colitis Ozanimod for treating moderately to severely active ulcerative colitis Technology appraisal guidance Published: 5 October 2022 www.nice.org.uk/guidance/ta828 © NICE 2022. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Your responsibility The recommendations impact of implementing NICE recommendations wherever possible. Ozanimod for treating moderately to severely active ulcerative colitis (TA828)© NICE 2022. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Page 2 of18Contents 1 Recommendations
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                            Ozanimod Skip to main contentSwitch to basic HTML versionLanguage selectionFrançaisSearchSearch Canada.caSearchTopics menuMAINMENU You are here:Home Health Drug and health products Licensing, authorizing and manufacturing drug and health products Drug and health product review and approval Clinical information on drugs and health products Search for clinical information on drugs and medical
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                            Ozanimod for treating relapsing–remitting multiple sclerosis Ozanimod for treating relapsing–remitting multiple sclerosis Technology appraisal guidance Published: 9 June 2021 www.nice.org.uk/guidance/ta706 © NICE 2021. 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 impact of implementing NICE recommendations wherever possible. Ozanimod for treating relapsing–remitting multiple sclerosis (TA706)© NICE 2021. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Page 2 of21Contents Contents 1 Recommendations
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                            2022Institute for Quality and Efficiency in Healthcare (IQWiG)
                            Review Analysis
                            Appears Promising
                            ?
                            Ozanimod (ulcerative colitis) - Benefit assessment according to '35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ozanimod (Colitis ulcerosa) – Nutzenbewertung gemäß § 35a SGB V (Version 2.0; Status: 9 May 2022). Please note: This document was translated by an external translator and 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. A21-166 Ozanimod (ulcerative colitis) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A21-166 Version 2.0 Ozanimod (ulcerative colitis) 9 May 2022 Institute for Quality and Efficiency in Health Care
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                            Ozanimod (supplied as ozanimod hydrochloride) - Zeposia - relapsing remitting multiple sclerosis Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search and menusSearchSearch websiteSearchTopics menu * Jobs * Immigration * Travel * Business * Benefits * Health * Taxes * More
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                            2022Prescrire
                            Ozanimod (Zeposia) in multiple sclerosis. As ineffective and probably as toxic as fingolimod Prescrire IN ENGLISH - Spotlight ''Ozanimod (Zeposia°) in multiple sclerosis. As ineffective and probably as toxic as fingolimod'', 1 May 2022 {1}##LOC[OK]## {1} ##LOC[OK]## ##LOC[Cancel]## {1}##LOC[OK]####LOC[Cancel]## Register online| Log in| My Prescrire Issue contents * Current issue * Last 12 network Offers * Subscribe now * Solidarity Subscription Rate * Subscribers: register online * Prescrire's other products * Free Special Edition * Sign up to receive the newsletter english.prescrire.org > Spotlight > 100 most recent > Ozanimod (Zeposia°) in multiple sclerosis. As ineffective and probably as toxic as fingolimod SpotlightEvery month, the subjects in Prescrire’s Spotlight. 100
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                            2023CADTH - Reimbursement Review
                            Review Analysis
                            Appears Promising
                            ?
                            Ozanimod (Zeposia) - Ulcerative colitis Return to Article DetailsOzanimod (Zeposia)
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                            2021Institute for Quality and Efficiency in Healthcare (IQWiG)
                            Review Analysis
                            Appears Promising
                            ?
                            Ozanimod (relapsing remitting multiple sclerosis) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ozanimod (multiple Sklerose) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 October 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. A20-59 Ozanimod (multiple sclerosis) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A20-59 Version 1.0 Ozanimod (multiple sclerosis) 13 October 2020 Institute for Quality and Efficiency in Health Care (IQWiG
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                            2021Institute for Quality and Efficiency in Healthcare (IQWiG)
                            Review Analysis
                            Appears Promising
                            ?
                            Ozanimod (multiple sclerosis) - Addendum to Commission A20-59 1 Translation of addendum A20-96 Ozanimod (multiple Sklerose) – Addendum zum Auftrag A20-59 (Version 1.0; Status: 10 December 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 10 December 2020 1.0 Commission: A20-96 Version: Status: IQWiG Reports – Commission No. A20-96 Ozanimod (multiple sclerosis) – Addendum to Commission A20-591 Addendum A20-96 Version 1.0 Ozanimod – Addendum to Commission A20-59 10 December 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality
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                            Ozanimod (Zeposia) Terms of use - Canada.ca * Skip to main content * Skip to "About government" Language selection * FrançaisSearchSearch Canada.ca Search Topics menuMain Menu You are here: 1. Home 2. Health 3. Drug and health products 4. Licensing, authorizing and manufacturing drug and health products 5. Drug and health product review and approval 6. Clinical information on drugs and health
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                            2022CADTH - Reimbursement Review
                            Review Analysis
                            Appears Promising
                            ?
                            Ozanimod (Zeposia) - Ulcerative colitis Return to Article DetailsOzanimod (Zeposia)
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                            2022Scottish Medicines Consortium
                            Ozanimod (Zeposia) - ulcerative colitis 1 Published 10 October 2022 1 SMC2478 ozanimod 0.23mg, 0.46mg and 0.92mg hard capsules (Zeposia®) Celgene Limited, a BMS Company 09 September 2022 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and following review by the SMC executive, 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 ozanimod (Zeposia®) is accepted for use within NHSScotland. Indication under review: for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent
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                            2020FDA - Drug Approval Package
                            Ozanimod (Zeposia) - To treat relapsing forms of multiple sclerosis Drug Approval Package: ZEPOSIA * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation
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                            2020European Medicines Agency - EPARs
                            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, 2021. Reproduction is authorised provided the source is acknowledged. EMA/610103/2021 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 the following diseases: • relapsing-remitting multiple sclerosis (RRMS). Multiple sclerosis is a disease in which the immune system (the body’s defences
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                            2021Scottish Medicines Consortium
                            Ozanimod (Zeposia) - relapsing remitting multiple sclerosis (RRMS) 1 Published 08 February 2021 1 SMC2309 ozanimod 0.23mg, 0.46mg and 0.92mg hard capsules (Zeposia®) Celgene Ltd 15 January 2021 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, 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 ozanimod (Zeposia®) is accepted for restricted use within NHSScotland. Indication under review: treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. SMC restriction: suitable for or requesting an oral
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                            GVS assessment of ozanimod (Zeposia) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) GVS assessment of ozanimod (Zeposia®) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) | Report | National Health Care Institute Go to content You are here: Home Publications GVS assessment of ozanimod (Zeposia®) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) Search within English part of National Health Care Institute Search GVS assessment of ozanimod (Zeposia®) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS)The National Health Care Institute has completed its assessment whether ozanimod (Zeposia®) for the treatment of adult patients with relapsing
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                            Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial. Patients with ulcerative colitis (UC) and prior biologic failure may have reduced or delayed efficacy with subsequent advanced therapies. This analysis evaluated the efficacy and safety of ozanimod during the True North (TN) study and its open-label extension (OLE) in biologic-exposed -controlled cohort, more ozanimod-treated patients achieved clinical response than placebo at W10 regardless of the number or type of prior biologics; patients who used 1 versus ≥2 prior biologics achieved higher efficacy rates. Efficacy rates were higher at W52 than W10 and were similar across subgroups regardless of the number or type of prior biologics. Significantly greater proportions of ozanimod vs
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                            2024Inflammatory Bowel Diseases
                            Pregnancy Outcomes in the Ozanimod Clinical Development Program in Patients With Ulcerative Colitis, Crohn's Disease, and Relapsing Multiple Sclerosis. This study evaluated pregnancy outcomes in patients with ulcerative colitis, Crohn’s disease, or multiple sclerosis and in healthy volunteers treated with ozanimod. There was no increased incidence of fetal abnormalities or adverse pregnancy outcomes with ozanimod exposure during early pregnancy.
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                            Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies. The pivotal phase 3 True North (TN) study demonstrated the efficacy and safety of ozanimod in patients with moderately to severely active ulcerative colitis. This analysis assessed ozanimod during TN and the ongoing open-label extension (OLE) in patients with active disease who were naive to advanced (OLE W46 and W94). Safety during TN was reported. This analysis included 616 AT-naive patients. Numerically greater proportions of patients receiving ozanimod than placebo achieved symptomatic response (39% vs 29%, 95% CI [-0.1, 18.8]) by W2, with significant differences (56% vs 39%, 95% CI [6.3, 26.3]) achieved by W4. Patients receiving ozanimod showed significant improvements across efficacy