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Takeda and TiGenix's Alofisel becomes first donor-derived stem cell therapy approved in Europe

Published on 26/03/18 at 10:53am

The European Commission has awarded approval to Takeda and TiGenix’s allogeneic expanded adipose-derived stem cell (eASC) therapy Alofisel (darvadstrocel) for the treatment of complex perianal fistulae in adult patients with nonactive/mildly active luminal Crohn’s disease, when fistulae have shown an inadequate response to at least one conventional or biologic therapy, it has emerged.

The decision makes Alofisel the first stem cell therapy originating from donor cells to secure approval in Europe, and was based on Phase 3 data which demonstrated that the treatment achieved statistically significant superiority in combined remission at 24 weeks. Follow-up studies also confirmed the treatment’s continued efficacy in maintaining long-term remission of treatment refractory complex perianal fistulae over 52 weeks.

As part of Takeda and TiGenix’s marketing partnership to develop and commercialise Alofisel outside the US, Takeda will make a payment of €15 million to TiGenix for securing authorisation for the treatment.

“Fistulating perianal Crohn’s disease represents one of the most challenging types of Crohn’s disease. It is challenging not only due to the difficult symptoms of pain and discharge, but particularly due to the major impact that these symptoms have on all aspects of life. This approval is a big step forward for patients with complex perianal fistulae in Crohn’s disease in the UK and has the potential to improve their quality of life,” commented Professor Ailsa Hart from St Mark’s Hospital and Imperial College, London. “Alofisel offers a novel and well-tolerated stem cell therapy treatment option for patients who do not respond to currently available therapies, and who have until now had limited treatment options available.”

Dr María Pascual, VP Regulatory Affairs and Corporate Quality at TiGenix, also added: “This approval of Alofisel reflects our deep understanding and recognised leadership in the development of allogeneic stem cells and our firm commitment to developing innovative therapies for medical needs. 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.”

Matt Fellows

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