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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

Registration application pending

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) in adults.
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

February 2024
Registration phase

Registration application pending

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 400-500 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.