Takeda and TiGenix have had their allogeneic stem cell therapy Alofisel approved for use by the EU, the first of its kind to be licensed in the 28-nation bloc.
Previously known as Cx601, the therapy is designed to aid milder and non-active forms of Crohn's disease by treating complex perianal fistulas. It will be used where one or more conventional treatments are shown to be ineffective.
“The first allogeneic stem cell therapy to be approved by the EU may substantially improve the treatment of Crohn's disease. “
Clinical trials showed that patients were 44 per cent more likely to gain remission from perianal fistulas compared to placebos, with this being confirmed by follow-up tests.
Speaking about the approval decision, Professor Ailsa Hart from St Mark’s Hospital and Imperial College, London said: "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.”
Takeda holds exclusive development rights for the treatment outside the US, and under terms of the deal the approval of Alofisel will trigger a EUR 15 million (GBP 13.1 million) payment to Tigenix.
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