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Mirum’s Livmarli (maralixibat) Receives EMA’s CHMP Positive Opinion for Cholestatic Pruritus in Patients with Alagille Syndrome

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Mirum’s Livmarli (maralixibat) Receives EMA’s CHMP Positive Opinion for Cholestatic Pruritus in Patients with Alagille Syndrome

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  • The EMA’s CHMP has adopted a positive opinion for Livmarli (IBAT inhibitor) to treat cholestatic pruritus in patients aged ≥2mos. with ALGS. The EC’s decision was expected at the end of 2022
  • The CHMP opinion was based on data from the (ICONIC) study incl. 5yrs. data across the Livmarli clinical program which showed durable and clinical improvements in cholestatic pruritus with a mean difference of -1.4 points and serum bile acids for patients with ALGS, both were durably maintained over several years of treatment
  • If Livmarli is approved in the EU, it will be the first approved treatment for Alagille syndrome. The therapy is currently being evaluated in late-stage clinical studies in other rare cholestatic liver diseases & has received BTD for ALGS and PFIC type 2 and ODD for ALGS, PFIC, and biliary atresia

Ref: Businesswire | Image: Mirum

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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 connect@pharmashots.com.

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