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Apabetalon

Extended indication Major adverse cardiovascular events (Diabetes Mellitus Type 2, Coronary Artery Disease, Cardiovascul
Therapeutic value No estimate possible yet
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).
Manufacturer Resverlogix
Mechanism of action BET inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks BET-protein inhibitor, facilitates endogenous ApoA-I production and raises HDL levels.

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Geen, betreft een nieuwe klasse.
Therapeutic value No estimate possible yet
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.
Frequency of administration 1 times a day
Dosage per administration 100 mg
References BETonMACE

Expected patient volume per year

Additional remarks Potentieel veel gebruikers (hoog risico cardio-patiënten met suikerziekte).

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.