Shots:

• Takeda will lead the regulatory approval and commercialization of maralixibat in Japan & will also be responsible for the development- including conducting clinical studies in cholestatic indications
• The collaboration will utilize Takeda’s leadership in rare disease- gastroenterology- and hepatology to advance the product in Japan
• Mirum has submitted a maralixibat’s NDA to the US FDA for cholestatic pruritus in patients with ALGS & is currently under priority review with an anticipated PDUFA date of Sep 29- 2021. Mirum also submitted an MAA to EMA for the same indication

Ref: Businesswire | Image: Takeda