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: Mirumpharma | Image: Mirumpharma
Related News:- Mirum’s Livmarli (maralixibat) Receives the Label Expansion Approval from the US FDA for Alagille Syndrome in Infants Aged ≥3 Months
