European Commission approves Takeda’s drug

By Brendan Grehan

THE EUROPEAN Commission has approved TiGenix and Takeda’s drug Alofisel 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.

Takeda has two facilities in Ireland, one in Grange Castle and one in Bray.


The Takeda facility in Grange Castle, Clondalkin

The approval follows a recent IDA announcement on February 28 that Takeda is to create up to 70 new jobs and invest €25m in the construction of a new regenerative medicine facility at its site in Grange Castle.

The investment will expand the site’s existing footprint with the construction of a new standalone modular cell therapy facility dedicated to manufacturing of this new treatment. The facility will be in commercial operation by 2021. This investment is supported by the Irish Government through IDA Ireland.

Andrew Williams, Consultant Colorectal Surgeon at Guy's and St. Thomas' NHS Foundation Trust told The Echo: “The availability of Alofisel provides a promising surgical option for those patients with complex Crohn's perianal fistula disease. 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.

"The use of a stem cell therapy exemplifies the importance of a strong multidisciplinary gastrointestinal team collaborating to achieve the best results for these patients with complex medical conditions.”

Shane Ryan, Country Head at Takeda Products Ireland feels that the marketing authorisation represents a positive advancement in the treatment of patients with complex perianal fistulae in Crohn’s disease. He added: “The recent investments towards the new local manufacturing site confirms Takeda’s commitment to its Irish operations continuing its 20 year long presence.

"The local team looks forward to continuing to put patients first with innovative new treatment options.”

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