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Elafibranor

Extended indication Treatment of primary biliary cholangitis (PBC).
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Elafibranor
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Liver diseases
Extended indication Treatment of primary biliary cholangitis (PBC).
Manufacturer Italfarmaco

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date October 2023
Expected Registration November 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Dosage per administration 80 mg
References NCT04526665

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.