Extended indication Symptomatic obstructive hypertrophic cardiomyopathy
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Aficamten
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Symptomatic obstructive hypertrophic cardiomyopathy
Manufacturer Cytokinetics
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 5 - 20 mg
References NCT06081894
Additional remarks Daily oral dose of 5mg, 10mg, 15mg or 20mg of aficamten

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 17,500.00
References G-standaard november 2023
Additional remarks Verwachting is dat de prijs per patiënt vergelijkbaar zal zijn met concurrent mavacamten. Kosten van mavacamten zijn ingeschat op €17.500 per patiënt per jaar.

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.