Bempedoic acid / ezetimibe

Extended indication	Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Bempedoic acid / ezetimibe
Domain	Cardiovascular diseases
Reason of inclusion	Indication extension
Main indication	Other medication for cardiovascular diseases
Extended indication	Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk.
Proprietary name	Nustendi
Manufacturer	Esperion
Portfolio holder	Daiichi Sankyo
Mechanism of action	Other
Route of administration	Oral
Therapeutical formulation	Film-coated tablet
Budgetting framework	Extramural (GVS)
Additional remarks	Esperion is een samenwerking gestart met Daiichi Sankyo voor het in de handel brengen van bempedoic acid. "First-in-class, small-molecule compound with a dual mechanism of action, inhibiting ATP citrate (pro-S)-lyase and stimulating AMP-activated protein kinase (AMPK). This inhibits fatty acid and cholesterol synthesis, and enhanced fatty acid oxidation."

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	August 2023
Expected Registration	June 2024
Orphan drug	No
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet
References	NCT02993406

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.