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Ustekinumab

Stelara

Extended indication Extension of indication to include treatment of moderately to severely active Crohn's disease in pae
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Ustekinumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Bowel diseases
Extended indication Extension of indication to include treatment of moderately to severely active Crohn's disease in paediatric patients weighing at least 40kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy or have medical contraindications to such therapies for STELARA
Proprietary name Stelara
Manufacturer Janssen
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks IL12/23-remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date July 2024
Expected Registration May 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Primary completion (estimated): 24 juli 2025.

Therapeutic value

Current treatment options IL-23-remmers (risankizumab, vedolizumab)
Therapeutic value No estimate possible yet
Substantiation De huidige behandelopties werken goed voor een grote groep van de pediatrische patiënten. Dit middel zal gaan concurreren met IL-23 remmers risankizumab (reeds geregistreerd voor Crohn) en guselkumab (nog niet geregistreerd voor IBD). Mirikizumab is ook in ontwikkeling. Ustekinumab is daarbij snel beschikbaar als biosimilar en zal dan zeer waarschijnlijk veel goedkoper zijn.
References NCT04673357 (CNTO1275CRD3004); Ziekte van Crohn. Farmacotherapeutisch kompas. 2024.

Expected patient volume per year

Patient volume

50 - 1

Market share is generally not included unless otherwise stated.
References Informatiepagina Crohn. Crohn & Colitis. 2024 (1).
Additional remarks In Nederland hebben ruim 100.000 mensen een chronische darmontsteking. Dit is ongeveer 1 op de 170 mensen. Hiervan heeft iets minder dan de helft de ziekte van Crohn (1). Er wordt verwacht dat het patiëntvolume laag zal uitvallen door de concurrentie op deze indicatie en het lagere aandeel van patiënten 2 tot 18 jaar.

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.