Rezafungin

Active substance
Rezafungin
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other infectious diseases
Extended indication
Patients With Candidemia and/or Invasive Candidiasis

1. Product

Proprietary name
Biafungin
Manufacturer
Cidara
Mechanism of action
Enzyme inhibitor
Route of administration
Intravenous
Therapeutical formulation
Injection
Budgetting framework
Intermural (MSZ)
Additional comments
Glucan synthase inhibitors

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Datum indiening en verwachte registratie op basis van estimated primary completion datum in september 2020.

3. Therapeutic value

Therapeutic value
No judgement
Substantiation
Verwacht wordt dat er zeker een plek is in de poliklinische setting.
Duration of treatment
Average 3 week / weeks
Frequency of administration
1 times a week
Dosage per administration
200 mg
References
NCT03667690

4. Expected patient volume per year

Patient volume

10 - 50

Market share is generally not included unless otherwise stated.

References
Hanemaaijer et al. Ned Tijdschr Med Microbiol 2016; 24 nr. 1
Additional comments
In Europa betreft de incidentie van invasieve candidiasis ongeveer 1-11 per 100.000 inwoners. Voor Nederland zou dit ongeveer 170-1.870 gevallen betreffen. De verwachting is dat enkele tientallen patiënten daadwerkelijk in aanmerking komen.

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

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.