Livmarli FDA Approval History
Last updated by Judith Stewart, BPharm on March 14, 2024.
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, Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis
Livmarli (maralixibat) is an ileal bile acid transporter (IBAT) inhibitor used for the treatment of cholestatic pruritus in patients with Alagille syndrome or progressive familial intrahepatic cholestasis.
- Livmarli is indicated for:
- the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS).
- the treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC).
Limitations of Use: Livmarli is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump (BSEP) protein. - Alagille syndrome is a rare genetic disorder characterized by abnormally narrow, malformed, or reduced numbers of bile ducts, and progressive familial intrahepatic cholestasis is a rare genetic disorder characterized by a reduced ability of the liver cells to secrete bile. The accumulation of bile acids in these conditions can lead to progressive liver disease, which may lead to liver failure. Symptoms include jaundice and severe pruritus.
- Livmarli works to treat cholestatic pruritus by inhibiting ileal bile acid transporter (IBAT) to reduce serum bile acid levels.
- Livmarli oral solution is usually administered once daily in patients with ALGS and twice daily in patients with PFIC. Livmarli should be taken 30 minutes before a meal.
- Warnings and precautions associated with Livmarli include liver test abnormalities, gastrointestinal adverse reactions, and fat-soluble vitamin (FSV) deficiency.
- Common adverse reactions in ALGS include diarrhea, abdominal pain, vomiting, fat-soluble vitamin deficiency, liver test abnormalities, and bone fractures.
Common adverse reactions in PFIC include diarrhea, fat soluble vitamin deficiency, abdominal pain, liver test abnormalities, hematochezia, and bone fractures.
Development timeline for Livmarli
Further information
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