Shots:
- The P-III (EXPAND) trial assessed Livmarli (285µg/kg, BID,PO) vs PBO for cholestatic pruritus in pts (≥6mos.; n=52: 6 adults & 46 pediatric) with ultra-rare cholestatic liver diseases, incl. biliary atresia (BA), achieving statistically significance across all 5 EPs
- In the pediatric population, Livmarli improved pruritus severity (ItchRO(Obs): −1.81 vs −0.83) & increased days with pruritus improvement (86% vs 49.1%). In the overall population, sBA levels decreased 70.1% with Livmarli vs 3.5% with PBO
- In BA pts with native liver, Livmarli improved pruritus severity (−2.16 vs −1.01), increased days with pruritus improvement (96.4% vs 52.2%) & reduced sBA levels by 75.5% vs 9.0% with PBO. Based on the results, FDA sNDA submission is planned in H1’27
Ref: Businesswire | Image: Mirum | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
