TiGenix and Takeda today announced that the European Commission has approved Alofisel for the treatment of Crohn’s disease. This marks the first allogeneic stem cell therapy to receive central marketing authorization approval (MA) in Europe.
The European approval follows a positive opinion by the European Medicines Agency Committee for Medicinal Products for Human Use , in conjunction with the Committee for Advanced Therapies, in December 2017. The recommendation was based on results from
TiGenix’s Phase III ADMIRE-CD pivotal trial as well as further follow-up data that indicated Alofisel maintained long-term remission in patients with Crohn’s disease over 52 weeks. Crohn's disease is a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract.
“I am extremely excited about this approval, which brings allogeneic [transplantation of cells, tissue, or organs coming from a donor that is not genetically identical to that of the recipient] stem cell therapy one step closer to patients in Europe,” said Professor Julian Panés, Head of the Gastroenterology Department at the Hospital Clinic of Barcelona 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," said 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 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.