Mirum’s Livmarli (maralixibat) Receives the Label Expansion Approval from the US FDA for Alagille Syndrome in Infants Aged ≥3 Months
Shots:
- The US FDA has approved a label expansion of Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome. Livmarli is supplied in a 30mL bottle & each mL contains 9.5mg of maralixibat
- The label expansion was based on the results from the (RISE) study evaluating Livmarli in infants aged ≤1yr. with ALGS which showed similar safety, tolerability, and PK in patients aged 3 to ≤12mos. & ≥12mos.
- Livmarli is currently approved for cholestatic pruritus in patients with ALGS in the US aged ≥3mos. and in the EU aged ≥2mos. The company has also submitted an sNDA for cholestatic pruritus in the US for patients with progressive familial intrahepatic cholestasis
Ref: Mirumpharma | Image: Mirumpharma
Related Post:- Mirum’s Livmarli (maralixibat) Receives EC’s Approval for Cholestatic Pruritus in Patients with Alagille Syndrome Aged ≥2 Months
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