Mirum Submits Application to the EMA for Marketing Authorization of Livmarli for Progressive Familial Intrahepatic Cholestasis
Shots:
- The company has submitted the variation application to the EMA for marketing authorization of Livmarli to extend the label in patients aged ≥2mos. The submission was based on the P-III study (MARCH) of Livmarli in 93 patients across a broad range of genetic PFIC types
- The results showed an improvement in pruritus, serum bile acids, bilirubin and growth, and maintenance of treatment effect, sustained reductions in serum bile acid & bilirubin levels with continuous pruritus improvement. The variation incl. interim analysis data from the OLE study (MARCH-ON)
- Livmarli was approved in the US & EU for cholestatic pruritus in patients with Alagille syndrome aged ≥3 & ≥2mos. The company also submitted an sNDA to the US FDA for cholestatic pruritus in patients aged ≥3mos. with PFIC
Ref: Mirum | Image: Mirum
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