Allogeneic stem cell therapy! Takeda Darvadstrocel Japan applied for listing

Takeda recently announced that it has submitted an application to Japan's Ministry of Health, Labour and Labour (MHLW) to produce and sell Darvadstrocel (development code: Cx601) for the treatment of complex fistula in adult patients with in activity/mild active tube crohn's disease (CD).
darvadstrocel is a heterogeneous (or supply source) amplified fat stem cell (eASC) suspension used to treat complex fistula in adult patients with in activityless or mildly active tube cavity CD.
darvadstrocel was awarded ODD status in the European Union, the United States and Japan in 2009, 2017 and 2019, respectively.
addition, Darvadstrocel has been awarded advanced regenerative medicine (RMAT) for the treatment of complex fistula in adult patients with CD by the FDA.
in the European Union, darvadstrocel was approved in March 2018 (trade name: Alofisel) for the treatment of complex fistula in patients with in activity/mild active cystic cavity CD.
darvadstrocel is used through topical dosing to treat complex fistula in adult patients with CD who are not responding enough to at least one conventional or biological therapy.
darvadstrocel should be used after fistula treatment.
application includes data from two clinical trials: the Japanese study Darvadstrocel-3002 and the ADMIRE-CD trials in Europe and Israel.
Darvadstrocel-3002 was a multi-center, open-label, non-controlled Phase 3 study conducted in 22 japanese adult in activity/mildly active tube cavity CD patients to assess the effectiveness and safety of Darvadstrocel's treatment of complex fistula.
the study will be presented at a recent scientific conference.
ADMIRE-CD was a randomized, double-blind, controlled Phase 3 clinical trial conducted in 212 adult patients with in activity/mildly active tube cavity CD who assessed the efficacy and safety of Darvadstrocel in the treatment of complex fistula.
(CD) is a chronic inflammatory disease of the digestive system that affects about 70,000 people in Japan.
with CD may experience complex fistula, which can cause severe pain, swelling, infections and secretions.
despite advances in medicine and surgery, complex fistula in CDs remains a challenge for clinicians and has a negative impact on the quality of life of patients.
original source: Takeda Submits New Drug Application Manufacture to Market Darvadstrocel In Japan for Treatment of Complex Perianal Fistulas in Adult Patients with Crohn's Disease This article was originally published from Bio Valley, for more information please download Bio Valley APP (