Here’s what you should know:
1. TiGenix started a phase III trial for Cx601 at the beginning of 2017. The company intends to submit that study for a U.S. Biologics License Application.
2. TiGenix’s Cx601 is for patients who had an inadequate response to a conventional or biologic therapy.
3. As a result of the designation, TiGenix is attempting to find expedited pathways to accelerate its FDA submission and review process.
TiGenix Vice President of Regulatory Affairs and Corporate Quality Maria Pascual, MD, said in a release, “The granting [of] orphan drug status by the FDA is a significant step forward in the Cx601 development program. The FDA’s recognition of Cx601 as an orphan drug brings a number of potential financial benefits and is aligned with our ongoing work seeking expedited pathways towards product approval in the U.S.”
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