Here’s what you should know.
1. The drug was approved as a treatment for fistulas in adult patients with inactive/mildly active luminal Crohn’s disease, where a conventional or biologic therapy was ineffective.
2. This marks the first time the European Commission approved an allogeneic stem cell therapy.
3. As a result of the approval Takeda will make a milestone payment to TiGenix of $18.65 million (€15 million).
4. TiGenix Vice President of Regulatory Affairs and Corporate Quality Maria Pascual, MD, said, “This approval of Alofisel reflects our deep understanding and recognized 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.”
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