Evolocumab Medicine 04 June 2026 Extended indication Extension of indication to extend the indication for REPATHA to include adults at high risk for a first cardiovascular event. Therapeutic value Total cost Registration phase Registration application pending Product Active substance Evolocumab Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Lipid-lowering medications Extended indication Extension of indication to extend the indication for REPATHA to include adults at high risk for a first cardiovascular event. Current proprietary name Already available biosimilars / generics Proprietary name Repatha Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date January 2026 Expected Registration August 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03872401 (VESALIUS-CV) 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 € 5,000.00 - 7,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References FK Additional remarks prijs per injectie ± €186; 2‑wekelijks gebruik) Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks