Basic Information
Livmarli
Regulatory Information
EMEA/H/C/005857
December 9, 2022
October 13, 2022
7
July 18, 2024
Company Information
Netherlands
Kingsfordweg 151 1043 GR Amsterdam
Mirum Pharmaceuticals International
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Livmarli is indicated for the treatment of: • Cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older, • Progressive familial intrahepatic cholestasis (PFIC) in patients 3 months of age and older.
Overview Summary
Livmarli is a medicine used for treating patients aged 2 months and older with cholestatic pruritus (intense itching due to a build-up of bile) caused by Alagille syndrome. It is also used for treating patients aged 3 months and older with progressive familial intrahepatic cholestasis. Alagille syndrome and progressive familial intrahepatic cholestasis are inherited diseases in which bile (a fluid produced in the liver that helps to break down fats) cannot drain properly from the liver, resulting in a build-up of bile acid in the liver and blood. One of the symptoms of this build-up is cholestatic pruritus. Intrahepatic cholestasis is associated with progressive liver damage and can lead to cirrhosis and end-stage liver impairment. These diseases are rare, and Livmarli was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the EMA website ( [Alagille syndrome](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1214); [progressive familial intrahepatic cholestasis](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1216)). Livmarli contains the active substance maralixibat chloride.