Elafibranor Medicine 05 December 2023 Extended indication Treatment of primary biliary cholangitis (PBC). Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Elafibranor Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Liver diseases Extended indication Treatment of primary biliary cholangitis (PBC). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Italfarmaco Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown 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 November 2024 Orphan drug Yes 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 80 mg References NCT04526665 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