First allogeneic stem cell therapy approved for use in EU

TiGenix and Takeda’s Alofisel has been approved by the European Commission for the treatment of complex perianal fistulas in adult Crohn’s disease sufferers.

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Alofisel, developed by TiGenix (Belgium) and licensed exclusively to Takeda (Osaka, Japan) for development and commercialization outside the US, is the first allogeneic stem cell-based therapy to receive approval for marketing in Europe. Alofisel, previously known as Cx601, consists of expanded adipose-derived stem cells and has been approved to treat complex perianal fistulas in adult patients with nonactive/mildly active luminal Crohn’s disease, when fistulas have not shown an adequate response to at least one conventional or biologic therapy.

“I am extremely excited about this approval, which brings allogeneic 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 (Spain) and President of the European Crohn's and Colitis Organization. “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.”

Following positive results in the phase III ADMIRE-CD pivotal trial, Alofisel received recommendations from the European Medicines Agency, Committee for Medicinal Products for Human Use and the Committee for Advanced Therapies in December 2017. The ADMIRE-CD trial demonstrated that patients receiving Alofisel had a 44% chance of achieving combined remission at 24 weeks, which was confirmed at 52 and 104 weeks.

“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,” said 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.”


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