Apremilast

Extended indication	Extension of indication to include treatment of moderate to severe chronic spontaneous urticaria in adults and adolescents 12 years and older, who are symptomatic despite treatment with H1 antihistamines and who are intolerant to or inadequately controlled by anti-IgE therapy for Dupixent.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Dupilumab
Domain	Chronic immune diseases
Reason of inclusion	Indication extension
Main indication	Other chronic immune diseases
Extended indication	Extension of indication to include treatment of moderate to severe chronic spontaneous urticaria in adults and adolescents 12 years and older, who are symptomatic despite treatment with H1 antihistamines and who are intolerant to or inadequately controlled by anti-IgE therapy for Dupixent.
Proprietary name	Dupixent
Manufacturer	Sanofi
Portfolio holder	Sanofi
Mechanism of action	Interleukin inhibitor
Route of administration	Subcutaneous
Therapeutical formulation	Injection liquid
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	February 2024
Expected Registration	November 2024
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet
References	NCT04180488

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

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.