Extended indication Resistant hypertension
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Aprocitentan
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Antithrombotic medications
Extended indication Resistant hypertension
Manufacturer Idorsia Pharmaceuticals
Mechanism of action Unknown
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Endothelin receptor antagonist.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date February 2023
Expected Registration March 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Dosage per administration 12,5mg - 25mg
References NCT03541174

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information