Expand all sections

Zalunfiban

Extended indication Treat ST-Elevated Myocardial Infarction.
Therapeutic value No estimate possible yet
Total cost 3,300,000.00
Registration phase Clinical trials

Product

Active substance Zalunfiban
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Treat ST-Elevated Myocardial Infarction.
Manufacturer CeleCor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Mogelijk data beschikbaar in 2024

Therapeutic value

Current treatment options Anticoagulants (eg, unfractionated heparin, enoxaparin, bivalirudin) Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (eg, clopidogrel, prasugrel, ticagrelor.
Therapeutic value No estimate possible yet
Substantiation Dit gaat om een enkele percutane interventie toediening. In de Celebrate studie wordt het getest on top of standard care (dus al dapt). Een voordeel zou minder trombusvorming zijn. In tegenstelling tot dit middel geeft bijvoorbeeld tirofiban (intraveneus beschikbaar) risico op trombocytopenie.
Duration of treatment one-off
Dosage per administration 0,110 mg/kg

Expected patient volume per year

Patient volume

11,000

Market share is generally not included unless otherwise stated.
References (1) https://www.hartstichting.nl/hart-en-vaatziekten/cijfers-hart-en-vaatziekten; (2) https://www.hartenvaatcijfers.nl/jaarcijfers/jaarcijfers-coronairlijden-a608f#h4;
Additional remarks In Nederland zijn er circa 32.000 acute hartinfarcten per jaar.(1). Primaire PCI bij STEMI is komt voor bij circa 30% van de patiënten. Het geschatte aantal is daardoor circa 11.000 per jaar (2).

Expected cost per patient per year

Cost 300.00
References medicijnkosten.nl
Additional remarks Er is nog geen prijsinformatie beschikbaar. Mogelijk is de prijs vergelijkbaar met, 250mg poeder voor injectie/infusieoplossing bivalirudin: kosten rond de €300.

Potential total cost per year

Total cost

3,300,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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.