Alofisel (darvadstrocel)
ATMP
- Region
- 🇪🇺 EU
- Active substance
- darvadstrocel
- Company
- Takeda Pharma A/S
- Status
- Withdrawn
- Therapeutic area
- Rectal Fistula
- CHMP opinion
- Thu 14 Dec 2017
- EU approval
- Fri 23 Mar 2018
- Designations
- ATMP
- Application
- EMEA/H/C/004258
- ATC
- L04
- Official record
- www.ema.europa.eu
Indication
Alofisel is indicated for the treatment of 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. Alofisel should be used after conditioning of fistula.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.