Mirum Pharmaceuticals' LIVMARLI Approved In The EU For Patients With PFIC In Patients 3-Months Of Age And Older

• European Commission grants LIVMARLI marketing authorization for treatment of PFIC in patients three months and older.
• Approval follows positive opinion from CHMP concluding LIVMARLI's clinical benefit over existing therapy in PFIC.
• LIVMARLI also received positive COMP opinion recommending maintenance of Orphan Drug Designation in PFIC.

Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) today announced that the European Commission has granted marketing authorization for LIVMARLI® (maralixibat) oral solution for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients three months of age and older. The approval follows a positive opinion by the CHMP which 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. Further, evaluation by COMP recommended maintenance of Orphan Drug Designation for LIVMARLI in PFIC.