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Budesonide

Kinpeygo

Extended indication Extension of indication to slow kidney function decline in adults with primary immunoglobulin A (IgA
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Budesonide
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Other chronic immune diseases
Extended indication Extension of indication to slow kidney function decline in adults with primary immunoglobulin A (IgA) nephropathy (IgAN).
Proprietary name Kinpeygo
Manufacturer Calliditas Therapeutics
Mechanism of action Immunosuppression
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date October 2023
Expected Registration August 2024
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03643965

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.