LIVMARLI tablet authorized in Canada for cholestatic pruritus in Alagille syndrome

Health Canada has authorized a tablet formulation of LIVMARLI for treating cholestatic pruritus in patients with Alagille syndrome, and Mirum said the authorization complements an existing 19 mg/mL oral solution option that was also authorized for related pediatric cholestatic conditions.

Health Canada has authorized a tablet formulation of LIVMARLI for the treatment of cholestatic pruritus in patients with Alagille syndrome. Mirum Pharmaceuticals announced the authorization and noted that tablet availability adds to dosing flexibility alongside an oral solution option. A company representative and a pediatric liver specialist commented that a tablet may provide an additional option to support treatment adherence and continuity of care. Key points: - Health Canada authorized LIVMARLI tablet formulation for treating cholestatic pruritus in patients with Alagille syndrome, as announced by Mirum Pharmaceuticals. - Mirum also reported an earlier authorization covering treatment of cholestatic pruritus in patients aged 12 months and older with progressive familial intrahepatic cholestasis (PFIC), and noted both the 19 mg/mL oral solution and tablet formulations were authorized to support flexible dosing. - Dr. Or Steg Saban of The Hospital for Sick Children, University of Toronto, said that a tablet option provides an additional choice that may support adherence and continuity of care for appropriate patients. - Alagille syndrome is a rare genetic disorder characterized by abnormally narrow, malformed, and reduced bile ducts, which can lead to bile accumulation, progressive liver disease, and involvement of multiple organ systems. - Reported signs of liver involvement in Alagille syndrome include jaundice, xanthomas, and severe pruritus; recent reports indicate 60% to 75% of patients with Alagille syndrome have a liver transplant before reaching adulthood. Summary: The authorization adds a tablet formulation of LIVMARLI to the treatment options described in the announcement, alongside an existing oral solution formulation. Undetermined at this time.