Takeda Submits Application for Darvadstrocel in Japan to Treat Complex Perianal Fistulas in Crohn’s Disease Patients

February 19, 2021 News /Bio ValleyBIOON/ -- Takeda Pharmaceutical Company Limited (Takeda) recently announced that it has submitted an application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for the manufacture and marketing of darvadstrocel (development code: Cx601) for the treatment of complex perianal fistulas in adult patients with non-active or mildly active luminal Crohn's disease (CD).

Darvadstrocel is an allogeneic (or donor-derived) expanded adiposeStem Cells(eASC) suspension for the treatment of complex perianal fistulas in adult patients with non-active or mildly active luminal Crohn's disease (CD). Darvadstrocel was granted Orphan Drug Designation (ODD) in the European Union, the United States, and Japan in 2009, 2017, and 2019, respectively. Furthermore, darvadstrocel has also been approved by the U.S.FDAApproved for the treatment of complex perianal fistulas in adult patients with Crohn's diseaseRegenerative MedicineRegenerative Medicine Advanced Therapy (RMAT).

In the European Union, darvadstrocel was approved in March 2018 (brand name: Alofisel) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease. Darvadstrocel is administered locally for the treatment of complex perianal fistulas in adult patients with Crohn’s disease who have had an inadequate response to at least one conventional or biologic therapy. Darvadstrocel should be used after fistula tract preparation.

The current application documents include data from two clinical trials: the Japanese study Darvadstrocel-3002 and the ADMIRE-CD trial conducted in Europe and Israel. Darvadstrocel-3002 is a multicenter, open-label, non-controlled Phase 3 study involving 22 Japanese adult patients with non-active or mildly active luminal Crohn’s disease (CD), evaluating the efficacy and safety of darvadstrocel for the treatment of complex anal fistulas. The results of this study will be presented at an upcoming scientificMeetingpublished. ADMIRE-CD is a randomized, double-blind, controlled Phase 3Clinical Trial, conducted in 212 adult patients with non-active/mildly active luminal Crohn's disease to evaluate the efficacy and safety of darvadstrocel in the treatment of complex perianal fistulas.

Crohn’s disease (CD) is a chronic inflammatory disorder of the digestive system, affecting approximately 70,000 individuals in Japan. Patients with CD may develop complex perianal fistulas, which can cause severe pain, swelling, infection, and anal discharge. Despite advances in medical and surgical treatments, complex perianal fistulas in CD remain a therapeutic challenge for clinicians and adversely affect patients’ quality of life.. (Bioon.com)

Original Source: Takeda Submits New Drugapplication to Manufacture and Market Darvadstrocel In Japan for Treatment of Complex Perianal Fistulas in Adult Patients with Crohn’s Disease