TiGenix and Takeda’s Alofisel has won clearance from the European Commission, making it the first allogeneic stem cell therapy to be approved for use in Europe.

Alofisel, previously known as Cx601, has been cleared to treat complex perianal fistulas in patients with Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.

Perianal fistulas are a common complication of Crohn’s disease and usually develop as an abnormal passageway between the anus and the skin after an infection, leading to pain, incontinence and recurrent abscesses.

The approval was based on results from a Phase 3 clinical trial, in which patients receiving Alofisel showed a 44% greater probability of achieving combined remission compared to a placebo.

“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,” said Julian Panés, head of the gastroenterology department at the Hospital Clinic of Barcelona in Spain, and president of the European Crohn’s and Colitis Organisation (ECCO).

Takeda holds exclusive development and commercialization rights to Alofisel outside the US, under an agreement made with TiGenix in July 2016 to bring new treatment options to patients with gastrointestinal orders. 

In an extension of that agreement, the Japanese group made a takeover bid for TiGenix this January, The marketing approval is one of the conditions required to complete the acquisition. It also means that TiGenix is now eligible to receive a milestone payment of €15 million.