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Takeda’s Alofisel becomes Europe’s first allogeneic stem cell therapy

Will treat perianal fistulas in adult patients with Crohn’s disease

Takeda

Takeda has chalked up a big win this week after receiving a European licence for Alofisel (darvadstrocel), marking the first approved allogeneic stem cell therapy set to hit the EU market.

Alofisel - previously Cx601 - is approved to treat complex perianal fistulas in adult patients with nonactive or mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.

The European approval follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) last December, which gave its recommendation based on results from ADMIRE-CD, a phase III trial.

Results from that trial showed that Alofisel achieved statistically significant superiority versus the control group in the primary efficacy endpoint of combined remission at 24 weeks.

Moreover, follow-up data indicated Alofisel maintained long-term remission of patients with the same indication for over 52 weeks.

Dr Asit Parikh, head of gastroenterology therapeutic area unit at Takeda, said: “Today’s marketing authorisation, the first for an allogeneic stem cell therapy, represents a positive advancement in the treatment of patients with complex perianal fistulas In Crohn’s disease.

“We look forward to brining this much needed treatment option to patients across Europe in the coming months.”

Alofisel, which works by a local administration of allogeneic expanded adipose-derived stem cells (eASCs), was initially manufactured at Belgian biopharma TiGenix, which entered into a licensing agreement with Takeda.

This agreement saw the Japanese pharma firm acquire rights to develop and commercialise Alofisel outside the US.

Dr Maria Pascual, vice president of regulatory affairs and corporate quality at TiGenix, said: “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.”

TiGenix has another adipose-derived product, Cx611, which is currently undergoing a phase I/II trial in severe sepsis.

Article by
Gemma Jones

27th March 2018

From: Regulatory

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