Mirum Submits Application to the EMA for Marketing Authorization of Livmarli for Progressive Familial Intrahepatic Cholestasis
- 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
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at email@example.com.