Livmarli FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 28, 2021.
FDA Approved: Yes (First approved September 29, 2021)
Brand name: Livmarli
Generic name: maralixibat
Dosage form: Oral Solution
Company: Mirum Pharmaceuticals, Inc.
Treatment for: Cholestatic Pruritus in Alagille Syndrome
Livmarli (maralixibat) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.
- Alagille syndrome is a rare genetic disorder characterized by abnormally narrow, malformed, or reduced numbers of bile ducts which leads to accumulation of bile acids and progressive liver disease. Symptoms include jaundice, xanthomas, and severe pruritus.
- Livmarli works to treat the pruritus associated with Alagille syndrome by inhibiting ileal bile acid transporter (IBAT) to reduce serum bile acid levels.
- Livmarli oral solution is administered once daily, 30 minutes before the first meal of the day.
- Livmarli can cause serious adverse reactions including liver test abnormalities, gastrointestinal adverse reactions, and fat-soluble vitamin (FSV) deficiency.
- Common adverse reactions include diarrhea, abdominal pain, vomiting, fat-soluble vitamin deficiency, liver test abnormalities, gastrointestinal bleeding, and bone fractures.
Development timeline for Livmarli
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