Extended indication Secukinumab in combination with glucocorticoid taper regimen for treatment of giant cell arteritis i
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Secukinumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Cardiovascular diseases
Extended indication Secukinumab in combination with glucocorticoid taper regimen for treatment of giant cell arteritis in adults over 50 and elderly
Manufacturer Novartis
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks IL-17-remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2025
Expected Registration September 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Indieningsdatum en verwachte registratie op basis van informatie fabrikant.

Therapeutic value

Current treatment options Glucocorticosteroïden, MTX en tocilizumab
Therapeutic value No estimate possible yet
References NCT04930094 (GCAptAIN)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 14,282.00
References Prijs op basis van AIP pen 300 mg (€ 1098.65) en een Q4W doseringsregime in de onderhoudsfase.

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.