Selatogrel Medicine 04 December 2025 Extended indication Selatogrel monotherapy for preventive treatment of suspected acute myocardial infarction in adults and elderly with a recent history of myocardial infarction. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Selatogrel Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Selatogrel monotherapy for preventive treatment of suspected acute myocardial infarction in adults and elderly with a recent history of myocardial infarction. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Viatris Portfolio holder 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 September 2026 Expected Registration October 2027 Orphan drug No Registration phase Clinical trials 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 Selatogrel werkt mogelijk sneller dan orale geneesmiddelen, maar moet nog aantonen dat het effectiever is dan bestaande behandelingen zoals ticagrelor. De huidige studies zijn nog beperkt, er is nog geen directe vergelijking met andere middelen gedaan en het gebruik richt zich op relatief kleine patiëntgroepen. Hoewel het potentieel interessant is, moeten de resultaten van lopende onderzoeken nog worden afgewacht. Duration of treatment Frequency of administration Dosage per administration References NCT04957719 (SOS-AMI); Expertopinie Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References vzinfo.nl Additional remarks In 2023 waren er in Nederland 66.500 nieuwe patiënten met een acuut myocardinfarct (AMI). Expected cost per patient per year Cost € 31,000.00 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 Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (B01AC) geneesmiddelen in Nederland (exclusief heparine). 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