Extended indication Treatment of patients with non-segmental vitiligo
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Ritlecitinib
Domain Chronic immune diseases
Reason of inclusion Indication extension IND
Main indication Skin diseases
Extended indication Treatment of patients with non-segmental vitiligo
Proprietary name Litfulo
Manufacturer Pfizer
Portfolio holder Pfizer
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks Werkingsmechanisme: Selectieve JAK3/TEC kinase remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date November 2026
Expected Registration December 2027
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet

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

Substantiation In de TRANQUILLO en TRANQUILLO 2 fase 3 studies wordt ritlecitinib vergeleken met placebo. Er zijn nog geen resultaten bekend.
Frequency of administration 1 times a day
Dosage per administration 50mg of 100mg
References NCT05583526 (TRANQUILLO); NCT06072183 (TRANQUILLO 2); NCT06163326 (TRANQUILLO LTE)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

References https://www.huidmedischcentrum.nl/
Additional remarks In Nederland hebben naar schatting circa 150.000 mensen vitiligo. Hiervan heeft ongeveer 80 tot 90% de non-segmentale vorm (NSV), wat neerkomt op 120.000 tot 135.000 mensen.

Expected cost per patient per year

References Taxe november 2025
Additional remarks De apotheek inkoopprijs is €640,30 (exclusief BTW) per verpakking van 30 stuks in de dosering van 50mg.

Potential total cost per year

Off label use

Off label use No

Indication extension

Indication extensions Unknown

Other information