Apabetalon

Active substance
Apabetalon
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
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)

1. Product

Manufacturer
Resverlogix
Mechanism of action
BET inhibitor
Route of administration
Oral
Therapeutical formulation
Capsule
Budgetting framework
Extramural (GVS)
Additional comments
BET-protein inhibitor, facilitates endogenous ApoA-I production and raises HDL levels

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials

3. Therapeutic value

Current treatment options
geen, betreft een nieuwe klasse
Therapeutic value
No judgement
Substantiation
Epigenetisch, meerdere aangrijpingspunten. Nu onderzocht bij post infarct patiënten met Diabetes Mellitus die een lage HDL waarde hebben. Afwachten resultaten van het lopende BetonMace onderzoek.
Duration of treatment
Not found
Frequency of administration
1 times a day
Dosage per administration
100 mg
References
BETonMACE

4. Expected patient volume per year

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

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.