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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

Sep 29, 2021Approval FDA Approves Livmarli (maralixibat) for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome
Mar 29, 2021Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome
Feb  1, 2021Mirum Pharmaceuticals Announces Completion of Rolling NDA Submission for Maralixibat in Alagille Syndrome
Sep  1, 2020Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access Program
Dec 16, 2019Mirum Pharmaceuticals Completes Successful Pre-NDA Meeting with FDA for Maralixibat
Nov  8, 2019Mirum Pharmaceuticals Presents Data Demonstrating Long-term Durability of Treatment Effect of Maralixibat in Children With Cholestatic Liver Diseases
Oct 28, 2019Mirum Pharmaceuticals Announces Breakthrough Therapy Designation for Maralixibat for the Treatment of Pruritus Associated with Alagille Syndrome
Jul  9, 2019Mirum Pharmaceuticals Initiates Phase 3 Clinical Trial of Maralixibat for Pediatric Patients with Progressive Familial Intrahepatic Cholestasis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.