Europe Approves Mirum Pharma's Drug For Rare Genetic Liver Disease

The European Commission has approved Mirum Pharmaceuticals Inc's MIRM Livmarli (maralixibat) oral solution for cholestatic pruritus in patients with Alagille syndrome (ALGS) two months of age and older.
ALGS is a rare genetic disorder in which bile ducts are abnormally narrow, malformed, and reduced in number, which leads to bile accumulation in the liver and, ultimately, progressive liver disease.
Livmarli is also approved by the FDA and the Israeli Ministry of Health for cholestatic pruritus in patients with ALGS one year and older.
Related: Analysts Expect Mirum Pharma's Liver Disease Candidate Might Exceed Rival Product's Penetration.
The European Commission's approval is based on data from the pivotal ICONIC study.
The data exhibited a statistically significant and clinically meaningful reduction in pruritus compared to placebo, with a mean difference of -1.4 points and significant reductions in serum bile acids.
The label also includes reductions in xanthoma severity and cholesterol.
Price Action: MIRM shares are up 2.76% at $19 on the last check Tuesday.