Bempedoic acid / ezetimibe Medicine 05 December 2023 Extended indication Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Bempedoic acid / ezetimibe Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other medication for cardiovascular diseases Extended indication Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk. Current proprietary name Already available biosimilars / generics Proprietary name Nustendi Manufacturer Esperion Portfolio holder Daiichi Sankyo Mechanism of action Other Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Esperion is een samenwerking gestart met Daiichi Sankyo voor het in de handel brengen van bempedoic acid. "First-in-class, small-molecule compound with a dual mechanism of action, inhibiting ATP citrate (pro-S)-lyase and stimulating AMP-activated protein kinase (AMPK). This inhibits fatty acid and cholesterol synthesis, and enhanced fatty acid oxidation." Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2023 Expected Registration June 2024 Orphan drug No 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 NCT02993406 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