TiGenix and Takeda’s Alofisel has become the first allogeneic stem cell therapy to be approved for use across the European Union.

The therapy (previously referred to as Cx601) has been cleared to treat complex perianal fistulas in adult patients with nonactive/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.

Perianal fistulas, a common complication of Crohn’s disease, occur when an abnormal passageway develops between the rectum and the outside of the body, potentially leading to incontinence and sepsis. Complex fistulas, which are rare, are more treatment resistant than simple fistulas.

Alofisel (darvadstrocel) is a local administration of allogeneic (donor derived) expanded adipose-derived stem cells (eASCs).

In clinical trials, patients receiving the treatment showing a 44 percent greater probability of achieving combined remission compared to placebo, while a follow-up analysis (at 52 weeks and 104 weeks post-treatment) confirmed sustained efficacy and safety.

“Fistulating perianal Crohn’s disease represents one of the most challenging types of Crohn’s disease,” noted Professor Ailsa Hart from St Mark’s Hospital and Imperial College, London. “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.”

“To date, surgical treatment for this challenging group has been very disappointing, it is hoped that with the adjunct of stem cell therapy, significant improvements can be made in fistula healing rates,” added Mr Andrew Williams, consultant colorectal surgeon at Guy's and St. Thomas' NHS Foundation Trust.

Takeda holds exclusive development and commercialisation rights to Alofisel outside the US under a deal with Tigenix, which now stands to receive a milestone payment of 15 million Euros triggered by approval of the therapy.