Extended indication Extension of indication to include treatment of adolescent patients (12 to less than 18 years) with severe alopecia areata.
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Baricitinib
Domain Chronic immune diseases
Reason of inclusion Indication extension IND
Main indication Other chronic immune diseases
Extended indication Extension of indication to include treatment of adolescent patients (12 to less than 18 years) with severe alopecia areata.
Proprietary name Olumiant
Manufacturer Eli Lilly
Mechanism of action JAK tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2025
Expected Registration March 2026
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

References NCT05723198 (I4V-MC-JAIO)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

References G-standaard
Additional remarks De prijs voor een verpakking van 28 tabletten Olumiant 4mg bedraagt €820,93

Potential total cost per year

Off label use

Indication extension

Other information