First 'off-the-shelf' stem cell therapy gains central authorization in EU

Japanese pharma company Takeda Pharmaceutical (TYO: 4502) and the Belgian biopharma that it is in the process of acquiring, TiGenix, achieved a notable milestone on Friday with the European Commission’s approval of Alofisel (darvadstrocel).

It has been approved for the treatment of complex perianal fistulas in adults with non-active/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy, and is the first ‘off-the-shelf’ stem cell therapy to receive central marketing authorization (MA) approval in Europe.

The decision is not a surprise as it 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.