Dupilumab Medicine 04 June 2024 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 Total cost Registration phase Registration application pending Product Active substance Dupilumab Domain Chronic immune diseases Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics 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) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date February 2024 Expected Registration November 2024 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04180488 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks