Mirum Pharmaceuticals’ Livmarli Receives the EC’s Approval to Treat Progressive Familial Intrahepatic Cholestasis (PFIC)


Following the CHMP’s positive opinion, the EC has approved Livmarli oral solution to treat progressive familial intrahepatic cholestasis patients (≥3mos.). It has also been designated with EC’s ODD for PFIC
The approval was supported by P-III (MARCH) trial among 93 patients for treating various genetic PFIC, showing reduced pruritus & serum bile acids across all-PFIC arm (n=64) plus improved total bilirubin & growth with common TEAEs of mild, transient diarrhea
Mirum has submitted an sNDA for higher concentration formulation to the US FDA, expanding the label for younger PFIC patients, with the decision anticipated in H2’24. It was approved in the US to treat cholestatic pruritus in PFIC patients (≥5yrs.)

Ref: Mirum Pharmaceuticals | Image: Mirum Pharmaceuticals

Related News:- Mirum Pharmaceuticals’ Livmarli (maralixibat) Receives the CHMP’s Positive Opinion for Progressive Familial Intrahepatic Cholestasis (PFIC)

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