Apabetalon Medicine 12 June 2019 Extended indication Major adverse cardiovascular events (Diabetes Mellitus Type 2, Coronary Artery Disease, Cardiovascular Diseases). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Apabetalon Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Major adverse cardiovascular events (Diabetes Mellitus Type 2, Coronary Artery Disease, Cardiovascular Diseases). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Resverlogix Portfolio holder Mechanism of action BET inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks BET-protein inhibitor, facilitates endogenous ApoA-I production and raises HDL levels. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Geen, betreft een nieuwe klasse. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Epigenetisch, er zijn meerdere aangrijpingspunten. Nu wordt het onderzocht bij post infarct patiënten met Diabetes Mellitus die een lage HDL waarde hebben. We moeten afwachten op de resultaten van het lopende BetonMace onderzoek. Duration of treatment Frequency of administration 1 times a day Dosage per administration 100 mg References BETonMACE 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 Potentieel veel gebruikers (hoog risico cardio-patiënten met suikerziekte). 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