Ozanimod

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.
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 remarks	Sphingosine 1 phosphate receptor modulator.

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

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

Additional remarks	Gemiddelde prijs per 28 stuks Zeposia, capsule 0,92mg €1.266,24

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.