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