ANX-005

Extended indication	Guillain-Barré Syndrome
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	ANX-005
Domain	Neurological disorders
Reason of inclusion	New medicine (specialité)
Main indication	Muscular diseases other
Extended indication	Guillain-Barré Syndrome
Manufacturer	Annexon
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	Complement C1 inhibitor

Registration

Registration route	Centralised (EMA)
ATMP	No
Submission date	June 2025
Expected Registration	July 2026
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Primary completion datum fase 3 studie in april 2024.

Therapeutic value

Current treatment options	IVIg is de therapie van eerste keuze bij de behandeling van GBS.
Therapeutic value	No estimate possible yet
Substantiation	Nog geen resultaten gepubliceerd. Aangezien het een eenmalige behandeling is en de prijs daarmee wellicht acceptabel kan blijven zal het potentieel IVIg kunnen gaan vervangen indien effectiviteit bevestigd wordt.
Dosage per administration	30mg/kg of 75mg/kg
References	NCT04701164 (ANX005-GBS-02)

Expected patient volume per year

Patient volume	< 200 Market share is generally not included unless otherwise stated.
References	Richtlijnendatabase.nl
Additional remarks	GBS is de meest frequente oorzaak van acute spierzwakte in de westerse wereld. De incidentie in Nederland bedraagt 1.3 op de 100.000 per jaar. Dat betekent dat er in Nederland per jaar ongeveer tweehonderd mensen GBS krijgen.

Patient volume

< 200

Market share is generally not included unless otherwise stated.

References

Richtlijnendatabase.nl

Additional remarks

GBS is de meest frequente oorzaak van acute spierzwakte in de westerse wereld. De incidentie in Nederland bedraagt 1.3 op de 100.000 per jaar. Dat betekent dat er in Nederland per jaar ongeveer tweehonderd mensen GBS krijgen.

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.