Allogeneic stem cell therapy! Takeda Darvadstrocel Japan applied for listing
Last Update: 2021-02-23
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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 an allogeneic (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. In 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 tube cavity CD. Darvadstrocel is used through topical dosing to treat complex fistula in adult patients with CD who are underreacting to at least one conventional or biological therapy. Darvadstrocel should be used after fistula treatment.
The filing 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-control 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 results of 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, evaluating the efficacy and safety of darvadstrocel in the treatment of complex fistula.
Crohn's disease (CD) is a chronic inflammatory disease of the digestive system that affects about 70,000 people in Japan. CD patients may experience complex fistula, which can cause severe pain, swelling, infections, and secretions. Despite advances in medicine and surgery, complex fistulas in CDs remain a challenge for clinicians and have a negative impact on the quality of life of patients. (Bio Valley)
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