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 Registration application pending

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 ora biologic agent for Zeposia.
Proprietary name Zeposia
Manufacturer Celgene
Mechanism of action Immunosuppression
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional comments Sphingosine 1 phosphate receptor modulator.

Registration

Registration route Centralised (EMA)
Submission date October 2020
Expected Registration October 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Additional comments 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.