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Mirum Announces Label Expansion for LIVMARLI in the United States to Include Infants Three Months of Age and Older
- LIVMARLI immediately available for prescribing for patients three months of age and older FOSTER CITY, Calif.--(BUSINESS WIRE)-- Mirum Pharmaceuticals,
About this update from Mirum Pharmaceuticals, Inc.
[{"type":"text","content":"\n- LIVMARLI immediately available for prescribing for patients three months of age and older\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nMirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a reduction in age from one year to three months for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). The label expansion was based on data from the RISE study which characterized the safety and tolerability of LIVMARLI in infants under one year of age with ALGS.\n\n“The vast majority of patients are diagnosed with ALGS before one year of age. The availability of LIVMARLI will offer an opportunity to introduce a treatment at the beginning of their ALGS journey with the goal of reducing serum bile acids and alleviating the unrelenting burden caused by pruritus,” commented Chris Peetz, president and chief executive officer at Mirum. “We are grateful to the patients and families who participated in the RISE study and made this important label expansion possible.”\n\nLIVMARLI is currently approved for the treatment of cholestatic pruritus in patients with ALGS in the U.S. (three months and older) and in Europe (two months and older). Additional information about LIVMARLI can be found on the product website, www.livmarli.com. Mirum has also submitted an sNDA in the United States for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis.\n\nAbout LIVMARLI® (maralixibat) oral solution\n\nLIVMARLI® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) three months of age and older and is the only FDA-approved medication to treat cholestatic pruritus associated with Alagille syndrome. For more information, please visit LIVMARLI.com.\n\nLIVMARLI is currently being evaluated in late-stage clinical studies in other rare cholestatic liver diseases including biliary atresia. LIVMARLI has received Breakthrough Therapy designation for ALGS and PFIC type 2 and orphan designation for ALGS, PFIC and biliary atresia. To learn more about ongoing clinical trials with LIVMARLI, please visit...