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Maralixibat

Livmarli

Extended indication Extension of indication to include treatment of Progressive Familial Intrahepatic Cholestasis (P
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Maralixibat
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Liver diseases
Extended indication Extension of indication to include treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients 2 months of age and older
Proprietary name Livmarli
Manufacturer Mirum Pharmaceuticals
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Solution
Budgetting framework Intermural (MSZ)
Centre of expertise UMC Groningen
Additional remarks Sodium-bile acid cotransporter inhibitor

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2023
Expected Registration February 2024
Registration phase Registration application pending

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.