The European Commission has approved Alofisel for the treatment of complex perianal fistulas in adult patients with nonactive-to-mild luminal Crohn’s disease who have shown inadequate response to at least one conventional or biologic therapy.
Alofisel (darvadstrocel; Takeda, TiGenix) is the first allogeneic stem cell therapy to receive central marketing authorization in Europe, according to a press release. The FDA issued orphan drug designation to the treatment in 2017.
“I am extremely excited about this approval, which brings allogeneic stem cell therapy one step closer to patients in Europe,” Julian Panés, MD, head of the gastroenterology department at the Hospital Clinic of Barcelona, Spain, and President of the European Crohn’s and Colitis Organisation (ECCO), said in a press release. “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.”
The approval follows phase 3 trial data showing that patients who received the treatment experienced significant benefits vs. controls for the primary efficacy endpoint of combined remission at 24 weeks. Additional follow-up data showed it also helped maintain long-term remission of refractory complex perianal fistulas in patients with Crohn’s disease over 52 weeks, according to the press release.
“Today’s marketing authorization, 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,” Asit Parikh, MD, PhD, head of Takeda’s gastroenterology therapeutic area unit, said in the press release.
Takeda recently announced plans to acquire TiGenix for more than 520 million euros. TiGenix entered into an exclusive licensing agreement in which Takeda acquired the right to develop and commercialize Alofisel outside the United States.
Healio Gastroenterology and Liver Disease was unable to confirm Panes’ relevant financial disclosures at the time of publication. Parikh is employed by Takeda.