Takeda Files Japan Marketing Application For Darvadstrocel In Crohn's Disease

Takeda Pharmaceutical Co Ltd (NYSE: TAK) has applied to the Japanese regulatory authority seeking approval for Darvadstrocel (Cx601) to treat complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn's disease. Darvadstrocel received an orphan drug designation in Japan in March 2019.
The application filing included data from two trials, the Japanese Study Darvadstrocel-3002 and the ADMIRE-CD trial, conducted in Europe and Israel. Takeda will present the data from Darvadstrocel-3002 at a scientific meeting soon.
Darvadstrocel is approved in the European Union, Israel, Switzerland, and the U.K. to treat complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn's disease when fistulas have shown an inadequate response to at least one conventional or biologic therapy.
Price Action: TAK shares closed 1.7% higher at $17.71 on Tuesday.