Extended indication

Patients with Atopic Dermatitis 12 Years and older.

Therapeutic value

No estimate possible yet

Registration phase

Clinical trials

Product

Active substance

Risankizumab

Domain

Chronic immune diseases

Reason of inclusion

Indication extension

Main indication

Skin diseases

Extended indication

Patients with Atopic Dermatitis 12 Years and older.

Proprietary name

Skyrizi

Manufacturer

Abbvie

Mechanism of action

Interleukin inhibitor

Route of administration

Subcutaneous

Therapeutical formulation

Injection

Budgetting framework

Intermural (MSZ)

Additional comments
IL-23 remmer

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Submission date

2022

Orphan drug

No

Registration phase

Clinical trials

Additional comments
De fabrikant geeft aan dat het niet bekend is wanneer registratie plaats vindt doordat het proces op dit moment 'on hold' is.

Therapeutic value

Current treatment options

Ciclosporine A, methotrexaat, azathioprine, mycofenolaat mofetil/mycofenolzuur en dupilumab

Therapeutic value

No estimate possible yet

References
NCT03706040

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost

15,000.00

References
Horizonscan Geneesmiddelen dupilumab;
Additional comments
De prijs voor risankizumab zal waarschijnlijk vergelijkbaar zijn met dupilumab. De prijs van dupilumab voor deze leeftijdsgroep bedraagt per patiënt per jaar: €15.000,70 (uitsluitend in het eerste jaar €576,95 erbij voor een éénmalige oplaaddosis).

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.