Mirum Pharmaceuticals, Inc. announced that its partner, Takeda Pharmaceutical Company Limited, received approval from the Japanese Ministry of Health, Labour, and Welfare for LIVMARLI (maralixibat) oral solution. This approval is for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) in Japan.
LIVMARLI is now the first and only medication available in Japan for patients suffering from pruritus related to ALGS and PFIC. This regulatory success expands LIVMARLI's global footprint, as it is already approved for ALGS in over 40 countries and for PFIC in over 30 countries worldwide.
Under the exclusive license agreement established in September 2021, Mirum is eligible to receive a percentage of Takeda's annual net sales from LIVMARLI in Japan. This approval represents a significant commercial milestone and a new revenue opportunity for Mirum.
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