Extended indication Extension of indication to include the treatment of moderate to severe chronic plaque psoriasis in c
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Apremilast
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Other chronic immune diseases
Extended indication Extension of indication to include the treatment of moderate to severe chronic plaque psoriasis in children and adolescents from the age of 6 years who have a contraindication, have an inadequate response, or are intolerant to at least one other systemic therapy or phototherap
Proprietary name Otezla
Manufacturer Amgen
Mechanism of action Enzyme inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Centre of expertise ErasmusMC, AMC/VUMC/READE
Additional remarks PDE4-inhibitor

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2023
Expected Registration September 2024
Orphan drug Yes
Registration phase Registration application pending
Additional remarks NCT04175613

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

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.