Fibrinogen

Active substance
Fibrinogen
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Hemostasis promoting medication
Extended indication
Patients With Congenital Fibrinogen Deficiency

1. Product

Manufacturer
Biotest
Mechanism of action
Coagulant
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
Stollingsfactor I, gepurificeerd uit humaan plasma.

2. Registration

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

3. Therapeutic value

Current treatment options
Bij Congenital Fibrinogen Deficiency is de behandeling met fibrinogeenconcentraat de eerste keuze (conform richtlijn hemofilie en aanverwante stollingsstoornissen). Er is op dit moment één alternatief voor fibrinogeenconcentraat genaamd Haemocomplettan op de markt.
Therapeutic value
Potential equal value
Substantiation
Naar verwachting zal fibrinogen voor deze indicatie beperkt in gebruik genomen worden.
Duration of treatment
Not found
References
NCT02065882
Additional comments
Wordt met name gebruikt bij behandelingen van korte duur.

4. Expected patient volume per year

Patient volume

17 - 153

Market share is generally not included unless otherwise stated.

References
Orphanet
Additional comments
De incidentie wordt geschat tussen de 1 en 9 per 1.000.000 inwoners. Voor Nederland betekent dit tussen de 17 en 153 patiënten.

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

Indication extension
Yes
Indication extensions
Acquired fibrinogen deficiency
References
Website Biotest
Additional comments
Zal met name gebruikt worden voor tekorten die optreden na groot trauma, bloedverlies en na bevallingen etc.

9. Other information

There is currently no futher information available.