Darvadstrocel, a drug for Crohn's disease in Takeda, was approved in Europe

Source: magic cube data 2018-03-26 March 24, Takeda pharmaceutical and tigenix announced that the European Commission has approved alofisel (darvadstrocel) (also known as CX601) for the treatment of complex perianal fistula in adult patients with inactive / mildly active intracavitary Crohn's disease, in which the fistula of these patients has insufficient response to at least one conventional or biotherapy Alofisel should be used after fistula treatment This approval marks Europe's first Ma approved allogeneic stem cell therapy Alofisel is a locally administered, allogeneic expanded fat stem cell (eascs) therapy for complex anal fistula in adult Crohn's disease patients who have not previously responded to at least one conventional therapy or biotherapy According to statistics, 28% of patients with Crohn's disease will be affected by perianal fistula in the first 20 years This stem cell product provides new treatment hope for such patients Prior to the approval of the treatment by the European Commission, in December 2017, the European Drug Administration (EMA) Committee on human medicinal products (CHMP), in collaboration with the Committee on advanced therapeutic drugs (CAT), had given positive comments on the approval of the treatment The decision to recommend approval is based on the results of the key phase 3 clinical trial of tigenix, admire-cd The results showed that at 24 weeks, alofisel was significantly better than the control group in the main efficacy endpoint of combined remission, and the difference was statistically significant Further follow-up data showed that alofisel could maintain long-term remission for more than 52 weeks Professor Julian pan é s, director of gastroenterology at the clinic of Barcelona hospital in Spain, said: "alofisel provides a new, minimally invasive, well tolerated alternative treatment for Crohn's disease patients, who have no response to the currently available treatment methods, and so far their treatment plans are limited." Dr Mar í a Pascual, vice president of quality and affairs management of tigenix, said: "this recognition of alofisel reflects our deep understanding and recognized leadership in the development of allogeneic stem cells We are firmly committed to the development of innovative therapies to meet medical needs We are pleased to provide the medical community with an important new treatment plan for patients with Crohn's disease who are not relieved by the currently available therapies " The exclusive development and commercialization rights and interests of alofisel outside the U.S region belong to Takeda pharmaceutical EU listing approval will trigger a 15 million euro milestone payment to be paid by Takeda to tigenix, which also marks the start of Ma transfer from tigenix to Takeda Dr asit Parikh, director of Takeda gastrointestinal treatment office, said: "today's marketing authorization is the first authorization for allogeneic stem cell treatment, marking the positive progress in the treatment of patients with complex anal fistula in Crohn's disease, and looking forward to providing this urgently needed treatment scheme for patients all over Europe in the next few months."