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Human normal immunoglobulin

HyQvia

Extended indication Extension of indication to include treatment of chronic inflammatory demyelinating polyneuropathy (C
Therapeutic value No estimate possible yet
Registration phase Registered and reimbursed

Product

Active substance Human normal immunoglobulin
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Neurological disorders other
Extended indication Extension of indication to include treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg for adults, children and adolescents (0 to 18 years).
Proprietary name HyQvia
Manufacturer Takeda
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date February 2023
Expected Registration January 2024
Orphan drug Yes
Registration phase Registered and reimbursed
Additional remarks Geregistreerd januari 2024

Therapeutic value

Current treatment options IVIg of SCIg.
Therapeutic value No estimate possible yet
Substantiation HyQvia is de subcutane immunoglobuline waarbij je ook hyaluronidase geeft. Het idee is om een grotere pocket subcutaan te maken en dat het daarmee meer en minder frequent toe te dienen is dan met andere SCIg preparaten. Er wordt verwacht dat het redelijk budget neutraal uitkomt en dat een kleine patiëntengroep zal overstappen van IVIg of SCIg naar deze tussenvorm.

Expected patient volume per year

Patient volume

400 - 500

Market share is generally not included unless otherwise stated.
References www.orpha.net (1);
Additional remarks De prevalentie van Chronische inflammatoire demyeliniserende polyneuropathie voor volwassenen bedraagt 1-7/100.000 volwassenen, maar algemeen wordt aangenomen dat dit onderschattingen zijn (1). Aangenomen wordt dat er 400 tot 500 mensen IVIG of SCIg gebruiken.

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.