First allogenic stem cell therapy approved by EC

The first allogenic stem cell therapy — Alofisel (darvadstrocel), previously Cx601, from TiGenix and Takeda Pharmaceutical Company — has received marketing authorisation approval from the European Commission for the treatment of complex perianal fistulas in Crohn’s disease.

This European approval follows a positive opinion that was granted 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.

“I am extremely excited about this approval, which brings allogeneic stem cell therapy one step closer to patients in Europe,” stated Professor Julian Panés, head of the Gastroenterology Department at the Hospital Clinic of Barcelona (Spain) and president of the European Crohn’s and Colitis Organisation (ECCO). “Alofisel offers a novel, minimally invasive and well tolerated alternative treatment option for patients with Crohn's disease who do not respond to currently available therapies, and who have until now had limited treatment options available.”

“This approval of Alofisel reflects our deep understanding and recognized leadership in the development of allogeneic stem cells and our firm commitment to developing innovative therapies for medical needs,” added Dr María Pascual, VP Regulatory Affairs and Corporate Quality at TiGenix. “We are pleased to offer the medical community an important new treatment option for patients with Crohn's disease who do not respond to currently available therapies.”

Alofisel has been licensed to Takeda for the exclusive development and commercialisation 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.

“Today's marketing authorisation, 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,” revealed Dr Asit Parikh, head of Takeda's Gastroenterology Therapeutic Area Unit. “We look forward to bringing this much needed treatment option to patients across Europe in the coming months.”