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Ozanimod

Zeposia

Extended indication Extension of indication to include the treatment of adult patients with moderately to severely activ
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Ozanimod
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Bowel diseases
Extended indication Extension of indication to include 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.
Proprietary name Zeposia
Manufacturer celgene
Mechanism of action Immunosuppression
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Sphingosine 1 phosphate receptor modulator.

Registration

Registration route Centralised (EMA)
Submission date October 2020
Expected Registration December 2021
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie ontvangen oktober 2021.

Therapeutic value

Current treatment options Vedolizumab, JAK-remmers, biologicals
Therapeutic value No estimate possible yet
Substantiation Nieuw werkingsmechanisme bij UC: functionele antagonist van de S1P1-receptor op lymfocyten, waardoor lymfocyten minder makkelijk migreren uit de lymfeklieren. Potentieel van meerwaarde voor UC-patiënten, die niet goed reageren of bijwerkingen hebben op andere geneesmiddelen daarnaast kan ook de orale toediening een voordeel zijn. Naar verwachting zal het ingezet worden na falen op 1e of 2e lijn biological en de concurrentie aangaan met vedolizumab.
Frequency of administration 1 times a day
Dosage per administration 0,92 mg
References NCT01647516

Expected patient volume per year

References Crohn-colitis.nl;
Additional remarks Colitis ulcerosa komt steeds vaker voor, met name in de westerse landen. Er zijn momenteel ruim 80.000 mensen in Nederland met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft ulcerative colitis. Er wordt verwacht dat er 200-300 patiënten in aanmerking zullen komen voor ozanimod.

Expected cost per patient per year

Cost 16,461.00
References medicijnkosten
Additional remarks Gemiddelde prijs per 28 stuks Zeposia, capsule 0,92mg €1.266,24.

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.