By Colin Kellaher

 

Mirum Pharmaceuticals Inc. on Tuesday said it signed an exclusive licensing agreement with Takeda Pharmaceutical Co. for maralixibat for rare pediatric liver diseases in Japan.

Mirum, a Foster City, Calif., biopharmaceutical company, said Takeda would be responsible for development, regulatory approval and commercialization of maralixibat in Japan for Alagille syndrome, progressive familial intrahepatic cholestasis and biliary atresia.

The U.S. Food and Drug Administration is currently reviewing Mirum's application for maralixibat to treat cholestatic pruritus, or itch, in patients with Alagille syndrome, with a target action date of Sept. 29.

Mirum, which earlier this month filed for European approval of maralixibat to treat cholestatic liver disease in patients with Alagille syndrome, said it is looking for partners outside the U.S. and Europe to expand the drug's global reach.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

September 21, 2021 08:39 ET (12:39 GMT)

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