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
Click here to read full press release/ article | Ref: Businesswire | Image: Linkedin
The post Takeda Enters into an Exclusive License Agreement with Mirum to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan first appeared on PharmaShots.
