Secukinumab

Extended indication	Secukinumab in combination with glucocorticoid taper regimen for treatment of giant cell arteritis in adults over 50 and elderly
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 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.

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

There is currently nothing known about the expected patient volume.

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

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.