Mirum Reports sNDA Submission to the US FDA for Livmarli (maralixibat) to Treat Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis
- The company has submitted an sNDA for Livmarli to the US FDA for cholestatic pruritus in patients aged ≥2mos. with PFIC. The submission was based on the P-III trial (MARCH PFIC) evaluating Livmarli in 93 patients across a range of genetic PFIC subtypes, incl. PFIC1/2/3/4/6 & unidentified mutational status
- The results showed an improvement in pruritus, serum bile acids, bilirubin & growth. The sNDA also incl. the P-II study (INDIGO) results of PFIC2 which showed a transplant-free survival in all serum bile acid responders after ≥5yrs.
- Livmarli was approved in the US & Israel for cholestatic pruritus in patients with ALGS aged ≥1yr. & in the EU for patients aged ≥2mos. The therapy is being studied in late-stage clinical studies for other rare cholestatic liver diseases
Ref: Businesswire | Image: Mirum
Related News:- Mirum’s Livmarli (maralixibat) Receives EC’s Approval for Cholestatic Pruritus in Patients with Alagille Syndrome Aged ≥2 Months
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