Posted by Michael Wonder on 06 Apr 2023
Mirum submits for European approval of Livmarli in progressive familial intrahepatic cholestasis
5 April 2023 - Application based on statistically significant and clinically meaningful improvements in serum bile acids, pruritus, bilirubin, and growth from the Phase 3 MARCH study.
Mirum Pharmaceuticals today announced submission to the EMA of a variation application to the marketing authorisation for Livmarli (maralixibat) oral solution, to extend the label for progressive familial intrahepatic cholestasis in patients two months of age and older.
