Alofisel® (darvadstrocel) from TiGenix and Takeda approved by the European Commission to treat complex perianal fistulas in Crohn's disease.

Chron’s disease is an inflammatory bowel disease that involves chronic inflammation of the gastrointestinal (GI) tract. It typically affects the end of the small bowel (the ileum) and the beginning of the colon, but can affect any part of the GI tract. The inflammation may lead to the formation of fistulas, tunnels between different loops of the intestine or between the intestine and the bladder, vagina, or skin, which require immediate attention. 

Many Chron’s disease patients with fistulas do not respond to current available therapies and as a result, may require numerous invasive surgeries to repair them. These patients may have new hope with the approval of Alofisel® (darvadstrocel) by the European Commission 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. It is the first allogeneic stem cell therapy to receive central marketing authorization approval in Europe. 

The approval was expected following the issuance of 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. 

Alofisel was developed by TiGenix NV, which has licensed to Takeda Pharmaceutical Company Limited exclusive development and commercialization of the drug outside of the US. As a result of the marketing approval, Takeda will pay TiGenic a milestone fee of €15 million, and the marketing approval will then be transferred to Takeda. 

Commented Dr. Asit Parikh, Head of Takeda's Gastroenterology Therapeutic Area Unit noted: "Today's marketing authorization, the first for an allogeneic stem cell therapy, represents a positive advancement in the treatment of patients with complex perianal fistulas in Crohn's disease. We look forward to bringing this much needed treatment option to patients across Europe in the coming months."