Mirum Pharmaceuticals’ Livmarli (maralixibat) Receives the CHMP’s Positive Opinion for Progressive Familial Intrahepatic Cholestasis (PFIC)
Shots:
- The CHMP has granted positive opinion to Livmarli (oral solution) for PFIC patients (age: ≥3mos.) along with COMP for maintaining ODD. EC’s decision is anticipated in Q3’24
- The opinions were supported by the P-III (MARCH) trial involving 93 patients with PFIC types (PFIC1, PFIC2, PFIC3, PFIC4, PFIC6 & unidentified mutational status), showing decreased pruritus severity
- In addition, the company has submitted an sNDA for Livmarli’s higher concentration formulation utilized in the MARCH trial, allowing label expansion among younger PFIC patients across the US. It will be introduced in H2’24
Ref: Mirum Pharmaceuticals | Image: Mirum Pharmaceuticals
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