Mirum Pharmaceuticals’ Livmarli Receives the EC’s Approval to Treat Progressive Familial Intrahepatic Cholestasis (PFIC)
Shots:
- 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
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
