Pelacarsen Medicine 03 June 2025 Extended indication Pelacarsen monotherapy for secondary prevention of major cardiovascular events in adults and elderly with established cardiovascular disease and increased levels of Lp(a). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Pelacarsen Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Lipid-lowering medications Extended indication Pelacarsen monotherapy for secondary prevention of major cardiovascular events in adults and elderly with established cardiovascular disease and increased levels of Lp(a). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Novartis Portfolio holder Mechanism of action Antisense oligonucleotide 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 November 2026 Expected Registration November 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van inschatting van de fabrikant. 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 1 times every 4 weeks Dosage per administration 80mg References NCT04023552 (Lp(a)HORIZON); NCT05305664; NCT06267560 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 De prijs in niet bekend. 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