EU approves Alofisel for Crohns disease, the first allogeneic stem cell therapy centrally approved in EU.- TiGenix + Takeda.
TiGenix and Takeda Pharmaceutical announced that the European Commission (EC) has approved Alofisel (darvadstrocel), previously Cx601, for the treatment of complex perianal fistulas in adult patients with nonactive/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.
This marks the first allogeneic stem cell therapy to receive central marketing authorization (MA) approval in Europe. The European approval follows a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), in conjunction with the Committee for Advanced Therapies (CAT), in December 2017.
The recommendation was based on results from TiGenix's Phase III ADMIRE-CD pivotal trial, which showed that Alofisel achieved statistically significant superiority versus the control group in the primary efficacy endpoint of combined remission at 24 weeks, as well as further follow-up data that indicated Alofisel maintained long-term remission of treatment refractory complex perianal fistulas in patients with Crohn's disease over 52 weeks.
Comment: Alofisel has been licensed to Takeda for the exclusive development and commercialization outside of the US. Receipt of the MA will trigger a milestone payment from Takeda to TiGenix of €15 million, and initiation of the process of transferring MA from TiGenix to Takeda.
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