Budesonide Medicine 05 December 2023 Extended indication Extension of indication to slow kidney function decline in adults with primary immunoglobulin A (IgA) nephropathy (IgAN). Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Budesonide Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Other chronic immune diseases Extended indication Extension of indication to slow kidney function decline in adults with primary immunoglobulin A (IgA) nephropathy (IgAN). Current proprietary name Already available biosimilars / generics Proprietary name Kinpeygo Manufacturer Calliditas Therapeutics Portfolio holder Mechanism of action Immunosuppression Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date October 2023 Expected Registration August 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 NCT03643965 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