Mirum’s Livmarli Receives Health Canada Authorization for Cholestatic Pruritus in Patients with Alagille Syndrome
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- Health Canada has authorized Livmarli (maralixibat oral solution) for cholestatic pruritus in patients with ALGS. The authorization was based on data from the P-IIb study (ICONIC) evaluating Livmarli in 31 patients aged 1–18yrs. with ALGS incl. 6yrs. of data across the Livmarli clinical program
- The results from the (ICONIC) study showed a reduction in pruritus over PBO as well as significant reductions in serum bile acids which were durably maintained over several years of treatment
- The studies showed robust & meaningful improvements for cholestatic pruritus associated with ALGS, published in The Lancet and Hepatology. Livmarli was approved in the US for cholestatic pruritus in patients with ALGS aged ≥3mos. & in the EU in the same indication aged ≥2mos.
Ref: Businesswire | Image: Mirum
Related News:- Mirum’s Livmarli (maralixibat) Receives the Label Expansion Approval from the US FDA for Alagille Syndrome in Infants Aged ≥3 Months
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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.
