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Obefazimod

Extended indication Treatment for patients with moderately to severely active ulcerative colitis who have inadequate res
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Obefazimod
Domain Chronic immune diseases
Reason of inclusion Indication extension
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
Manufacturer Abivax
Route of administration Oral
Therapeutical formulation Tablet
Additional remarks Er is nog geen besluit genomen over het bekostigingskader.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2024
Expected Registration September 2025
Registration phase Clinical trials

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
Substantiation First-in-class small molecule dat specifiek en selectief miR-124 upreguleert en zodoende de expressie van diverse inflammatoire cytokines onderdrukt. Effectief gebleken in fase 2 en fase 3 onderzoek in uitvoering.
Frequency of administration 1 times a day
Dosage per administration 25 or 50 mg
References NCT05507203

Expected patient volume per year

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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.