Mirum Pharmaceuticals announced that Health Canada has approved the tablet formulation of its IBAT inhibitor LIVMARLI for the treatment of cholestatic pruritus in patients with Alagille syndrome and Progressive Familial Intrahepatic Cholestasis (PFIC). The approval does not broaden the drug’s indications; it simply provides a new, more convenient formulation for the same patient groups that were already eligible for the liquid version.
The tablet is intended for patients who weigh more than 25 kg (approximately 22 kg in some sources) and can swallow solid dosage forms. By offering a single‑tablet regimen, Mirum improves adherence and reduces the burden of daily liquid dosing, which is especially valuable for adolescents and larger pediatric patients who are transitioning to adult care.
Mirum’s new formulation gives it a competitive edge over rivals such as Ipsen’s Bylvay, which is available only as an oral solution. The tablet format allows Mirum to capture a larger share of the growing cholestatic pruritus market, projected to grow at a 23.4% CAGR through 2034, and to differentiate its product in a crowded therapeutic space.
The approval is expected to accelerate revenue growth for Mirum’s flagship product and support the company’s broader strategy of expanding its rare‑disease portfolio. Mirum has already achieved strong sales momentum, with net product sales for LIVMARLI projected to reach $500 million–$510 million in 2025, and it continues to acquire complementary assets such as Bluejay Therapeutics and Travere’s bile‑acid portfolio to broaden its pipeline.
CEO Chris Peetz said, “This approval confirms the value of our patient‑centric approach and reinforces our commitment to delivering innovative therapies for rare liver diseases.” He added that the tablet formulation will help the company “capture a larger share of the market and improve the quality of life for patients who have limited treatment options.”
The Health Canada authorization positions Mirum to expand its commercial footprint in Canada and potentially in the U.S. and other international markets, where the company already has a presence. With the tablet now available, Mirum can target a broader patient base, enhance market penetration, and strengthen its competitive moat in the rare‑disease sector.
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