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Rezafungin

Biafungin

Extended indication Rezzayo is indicated for the treatment of invasive candidiasis in adults.
Therapeutic value Possible benefit in ease of use
Registration phase Positive CHMP opinion

Product

Active substance Rezafungin
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Fungal infections
Extended indication Rezzayo is indicated for the treatment of invasive candidiasis in adults.
Proprietary name Biafungin
Manufacturer Cidara
Mechanism of action Enzyme inhibitor
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Glucan synthase inhibitors

Registration

Registration route Centralised (EMA)
ATMP No
Submission date August 2022
Expected Registration December 2023
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie oktober 2023

Therapeutic value

Current treatment options Caspofungin.
Therapeutic value Possible benefit in ease of use
Substantiation Verwacht wordt dat er zeker een plek is in de poliklinische zetting. De data uit de fase 3 studie ReSTORE liet zien dat rezafungin non-inferieur is ten opzichte van caspofungin. De toediening van eenmaal per week biedt een voordeel in toedienginsgemak ten opzichte van caspofungin.
Duration of treatment Average 3 week / weeks
Frequency of administration 1 times a week
Dosage per administration 200 mg
References NCT03667690

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 remarks In Europa betreft de incidentie van invasieve candidiasis ongeveer 1 tot 11 per 100.000 inwoners. Voor Nederland zou dit ongeveer 170 tot 1.870 gevallen betreffen. De verwachting is dat enkele tientallen patiënten daadwerkelijk in aanmerking komen.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.