Obefazimod Medicine 05 December 2023 Extended indication Treatment for patients with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Obefazimod Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Bowel diseases Extended indication Treatment for patients with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abivax Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Centre of expertise Additional remarks Er is nog geen besluit genomen over het bekostigingskader. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Adalimumab, infliximab, golimumab, ustekinumab, vedolizumab, upadacitinib, ozanimod, filgotinib, tofacitinib en in de toekomst risankizumab, etrasimod en mirikizumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation First-in-class small molecule dat specifiek en selectief miR-124 up reguleert en zodoende de expressie van diverse inflammatoire cytokines onderdrukt. Effectief gebleken in fase 2 en fase 3 onderzoek in uitvoering. Duration of treatment Frequency of administration 1 times a day Dosage per administration 25mg of 50mg References NCT05507203 (ABTECT-1); NCT05507216 (ABTECT-2) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Crohn-colitis.nl (1); NVMDL Leidraad IBD (2); Additional remarks Colitis ulcerosa komt steeds vaker voor met name in de westerse landen. Er zijn momenteel ruim 90.000 mensen in Nederland met een chronische darmontsteking (1). Dit is ongeveer 1 op de 200 mensen. Doorgaans wordt gestart met een TNF-alfaremmer. Daarna worden ook andere biologische geneesmiddelen overwogen (2). In 2022 kregen 3.259 patiënten een biologisch geneesmiddel voorgeschreven anders dan TNFalfaremmers. Expected cost per patient per year Cost € < 15,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Medicijnkosten.nl; FK Additional remarks Er is nog niets bekend over de prijs van obefazimod, maar deze zou vergelijkbaar kunnen zijn met die van ozanimod. De prijs van een behandeling ozanimod is €14.935 per patiënt per jaar (exclusief BTW). Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks