Takeda Pharmaceutical Company Limited announced that it has submitted an application to the Japanese Ministry of Health, Labour and Welfare to manufacture and market darvadstrocel (development code: Cx601) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease (CD).
The application filing included data from two trials, the Japanese Study Darvadstrocel-3002 and the ADMIRE-CD trial, conducted in Europe and Israel. Study Darvadstrocel-3002 is a Phase 3, multicenter, open-label, uncontrolled study investigating the efficacy and safety of darvadstrocel for the treatment of complex perianal fistulas in 22 Japanese adult patients with non-active/mildly active luminal CD. Results from Study Darvadstrocel-3002 will be presented at a scientific meeting in the near future. ADMIRE-CD was a randomized, double-blind, controlled, Phase 3 trial investigating the efficacy and safety of darvadstrocel for the treatment of complex perianal fistulas in 212 adult patients with non-active/mildly active luminal CD.
Naoyoshi Hirota, General Manager of Takeda Development Center Japan said, “Complex perianal fistulas in Crohn's disease place a significant burden on patients and are a serious complication that greatly impacts quality of life. We are extremely grateful to the patients and healthcare professionals who cooperated in the development of this investigational medicine, and we are proud to have taken this first step toward the potential approval of a cell-mediated closure option for adult Crohn’s disease patients with complex perianal fistulas in Japan.”
Darvadstrocel received an orphan drug designation from Japan's Ministry of Health, Labour and Welfare on March 13, 2019 for potential efficacy, effects, or performance in treating complex perianal fistulas in adult patients with CD.6 Darvadstrocel received central marketing authorization approval in Europe in March 2018 for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal CD.
