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Mirum Pharmaceuticals’ LIVMARLI Approved in the European Union for Patients with PFIC
European Commission grants LIVMARLI marketing authorization for treatment of PFIC in patients three months and older. Approval follows positive opinion from
About this update from Mirum Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nEuropean Commission grants LIVMARLI marketing authorization for treatment of PFIC in patients three months and older.\n\n\n\nApproval follows positive opinion from CHMP concluding LIVMARLI’s clinical benefit over existing therapy in PFIC.\n\n\n\nLIVMARLI also received positive COMP opinion recommending maintenance of Orphan Drug Designation in PFIC.\n\n\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nMirum 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.\n\n\nThe approval is based on data from the Phase 3 MARCH study, the largest randomized trial conducted in PFIC, with 93 patients across a range of genetic PFIC types, including PFIC1, PFIC2, PFIC3, PFIC4, PFIC6, and unidentified mutational status. Data from MARCH showed statistically significant reduction in pruritus (p","length":1688,"tagName":"div"}]