Human stem cell embedded in a 3D matrix,. Credit: Flikr/Sílvia A Ferreira, Cristina Lopo and Eileen Gentleman, King’s College London, Wellcome Images.

TiGenix and Takeda have announced that Alofisel (darvadstrocel) has received EU approval for the treatment of complex perianal fistulas in Crohn’s disease.

The drug has been approved for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease where fistulas have not responded to at a conventional or biologic therapy.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Perianal fistulas occur when a channel develops between the end of the bowel and the skin near the anus and usually require surgical treatment. They are a severe and debilitating complication of Crohn’s disease for which there is currently no effective treatment.

Alofisel, which is TiGenix’s lead product, works by reducing the release of pro-inflammatory cytokines at inflammation sites.

It is the first allogeneic stem cell therapy to receive central marketing authorisation approval in Europe.

The European approval follows a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use in conjunction with the Committee for Advanced Therapies.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The recommendation was based on results from TiGenix’s Phase III pivotal trial, in which Alofisel performed better than placebo, showing a 44% greater probability of achieving combined remission.

In allogeneic treatments, stem cells are collected from a matching donor and transplanted into the patient to suppress the disease or restore the patient’s immune system. Cells do not have to come from the patient’s own body, meaning separate treatments do not need to be developed for individual patients.

Allogenic treatments are quicker and cheaper to manufacture and can be stored, meaning that the approval of a treatment of this kind is a significant step forward for stem cell therapy.

Vice-president of regulatory affairs and corporate quality at TiGenix Dr Maria Pascual 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.

“We are pleased to offer the medical community an important new treatment option for patients with Crohn’s disease who do not respond to currently available therapies.”

Alofisel has been licensed to Takeda for the exclusive development and commercialisation outside of the US. It was granted orphan drug designation by the EMA in 2009 and by the US Food and Drug Administration in 2017.

Crohn’s disease is a long-term condition that causes inflammation of the lining of the digestive system. There is currently no cure for the disease.