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Mirum Pharmaceuticals Announces Positive CHMP Opinion for LIVMARLI® (maralixibat) Oral Solution for Cholestatic Pruritus in Patients with Alagille Syndrome Two Months of Age and Older
- CHMP opinion based on pivotal ICONIC study with more than five years of data demonstrating durable and clinically meaningful improvements in cholestatic
About this update from Mirum Pharmaceuticals, Inc.
[{"type":"text","content":"\n- CHMP opinion based on pivotal ICONIC study with more than five years of data demonstrating durable and clinically meaningful improvements in cholestatic pruritus and serum bile acids for patients with Alagille syndrome (ALGS).\n\n- Following CHMP recommendation, a decision by the European Commission is expected by year-end 2022; if approved, LIVMARLI would be the first medication to treat cholestatic pruritus for patients with ALGS in Europe.\n\n- LIVMARLI also received approval by Israeli Ministry of Health for cholestatic pruritus in patients with Alagille syndrome one year of age and older; represents second regulatory approval in the indication and first approval outside of U.S.\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nMirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced two global advancements for LIVMARLI® (maralixibat) oral solution, an oral minimally absorbed ileal bile acid transporter (IBAT) inhibitor currently approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older.\n\nThe European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of LIVMARLI for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) two months of age and older. The CHMP positive opinion is the scientific recommendation to the European Commission for grant marketing authorization in Europe. LIVMARLI was previously approved by the U.S. Food and Drug Administration in 2021 as the first and only treatment for cholestatic pruritus in patients with ALGS one year of age and older.\n\nMirum also announced that its partner, Neopharm, received commercial and marketing authorization by the Israeli Ministry of Health, Israel’s regulatory agency responsible for the approval of new medicines, granting approval of LIVMARLI for the treatment of cholestatic pruritus in patients with ALGS one year of age and older.\n\n“LIVMARLI is the first and only medicine to receive CHMP positive opinion to address cholestatic pruritus in patients with Alagille syndrome and we are hopeful that this medication provides a meaningful treatment option for people suffering from this devastating disease,” said Chris Peetz, president and chief executive officer at Mirum. “Our experience with LIVMARLI in the U.S. has shown the impact it can have on th...