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Benralizumab

Fasenra

Extended indication Bulleus pemfigoïd
Therapeutic value No estimate possible yet
Registration phase No registration expected

Product

Active substance Benralizumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Other chronic immune diseases
Extended indication Bulleus pemfigoïd
Proprietary name Fasenra
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks Deze toediening is in navolging van de ernstig astma indicatie en de afbakeningsbrief 2014 een GVS-traject, aangevuld met een add-on, omdat behandeling in het ziekenhuis opgestart dient te worden onder toezicht van een specialist.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2024
Expected Registration November 2025
Orphan drug No
Registration phase No registration expected
Additional remarks NCT04612790 (FJORD) is terminated.

Therapeutic value

Current treatment options Corticosteroïden, azathioprine, mycofenolaat mofetil, methotrexaat, cyclofosfamide, erytromycine, tetracyclines in combinatie met nicotianine.
Therapeutic value No estimate possible yet
References NCT04612790 (FJORD)
Additional remarks n.t.b.

Expected patient volume per year

Patient volume

< 4,500

Market share is generally not included unless otherwise stated.
References Bulleus pemfigoïd. Orphanet. 2020 (1).
Additional remarks De prevalentie in Europa wordt geschat op 1 op de 4.000 (1).

Expected cost per patient per year

References Medicijnkosten.nl (1)
Additional remarks Benralizumab injectievloeistof 30mg/ml WWSP 1ml kost €2.537,09 (1).

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.