Extended indication Ulcerative colitis
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Alicaforsen
Domain Chronic immune diseases
Main indication Bowel diseases
Extended indication Ulcerative colitis
Proprietary name Oligo-TCS
Manufacturer Atlantic
Route of administration Rectal
Therapeutical formulation Enema
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Mesalazines (oraal/ topicaal), glucocorticoiden en budesonides (oraal/ topicaal), thiopurines (oraal), tacrolimus (oraal), anti-TNF (sc, iv), vedolizumab (iv)
Therapeutic value No judgement
References Van Deventer et al, Aliment Pharmacol Ther. 2006 May 15;23(10):1415-25; Miner et al, Aliment Pharmacol Ther. 2006 May 15;23(10):1427-34.
Additional remarks Nog te vroeg om iets over te zeggen. Alleen fase 2 studie en open label studie beschikbaar bij CU. Gaat voorlopig nog niet op de markt komen.

Expected patient volume per year

Patient volume

150

Market share is generally not included unless otherwise stated.

References Crohn-colitis.nl
Additional remarks Colitis ulcerosa komt steeds vaker voor, met name in de westerse landen. Er zijn momenteel ruim 80.000 mensen in Nederland met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft colitis. Inschatting bij concurrerende medicatie (etrolizumab, ustekinumab) is 150 patiƫnten.

Expected cost per patient per year

Additional remarks Waarschijnlijk hoge kosten

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

Indication extension No

Other information

There is currently no futher information available.