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Lanadelumab

Takhzyro

Extended indication TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in
Therapeutic value No estimate possible yet
Registration phase Registered and reimbursed

Product

Active substance Lanadelumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Other chronic immune diseases
Extended indication TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.
Proprietary name Takhzyro
Manufacturer Shire
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks Lanadelumab is een potent, specifiek, volledig humaan recombinant immunoglobuline G1 (IgG1) monoclonaal antilichaam dat bindt aan actief plasma kallikreïne en de activiteit remt. Gebonden aan plasma kallikreïne blokkeert lanadelumab splitsing van high molecular weight kininogen (HMWK) en daarmee de productie van bradykinine, waardoor de vorming van angio-oedeem voorkomen kan worden.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2023
Expected Registration August 2023
Orphan drug Yes
Registration phase Registered and reimbursed
Additional remarks Positieve CHMP-opinie in september 2023.

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

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.