CHMP positive opinion for Livmarli (maralixibat) oral solution for the treatment of progressive familial intrahepatic cholestasis in patients three months of age and older- Mirum Pharma.
Mirum Pharmaceuticals, Inc. announced that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Livmarli (maralixibat) oral solution for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients three months of age and older.
The CHMP also concluded that Livmarli in PFIC brings significant clinical benefit based on improved efficacy and a major contribution to patient care compared to the existing approved treatment for PFIC. The CHMP positive opinion is the scientific recommendation to the European Commission for marketing authorization in Europe.
In addition, the Committee for Orphan Medicinal Products (COMP), has also recommended maintenance of Orphan Drug Designation for Livmarli in PFIC. The European Commission’s endorsement of the CHMP and COMP opinions is expected in the third quarter of 2024.
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