TiGenix and Takeda have announced that Alofisel (darvadstrocel) has received EU approval for the treatment of complex perianal fistulas in Crohn’s disease.
The drug has been approved for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease where fistulas have not responded to at a conventional or biologic therapy.
Perianal fistulas occur when a channel develops between the end of the bowel and the skin near the anus and usually require surgical treatment. They are a severe and debilitating complication of Crohn’s disease for which there is currently no effective treatment.
Alofisel, which is TiGenix’s lead product, works by reducing the release of pro-inflammatory cytokines at inflammation sites.
It is the first allogeneic stem cell therapy to receive central marketing authorisation approval in Europe.
Read more: https://www.pharmaceutical-technology.com/news/eu-allogenic-crohns-alofisel/