Takeda Agrees With Mirum Pharma For Approval, Commercialization Of Maralixibat In Japan

(RTTNews) - Mirum Pharmaceuticals, Inc. (MIRM) and Takeda Pharmaceutical Company Limited (TAK) have entered into an exclusive licensing agreement for the development and commercialization of maralixibat in Japan for Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia. Under the agreement, Takeda will be responsible for regulatory approval and commercialization of maralixibat in Japan.

Mirum has submitted a new drug application to the FDA for maralixibat for the treatment of cholestatic pruritus in patients with Alagille syndrome. The NDA is currently under priority review with a PDUFA date of September 29, 2021.