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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.