Mirum’s Livmarli (maralixibat) Receives the Label Expansion Approval from the US FDA for Alagille Syndrome in Infants Aged ≥3 Months
- 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
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 email@example.com.