Takeda and TiGenix reported on Tuesday that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted for review the file on investigational compound Cx601 to treat complex perianal fistulas in patients with Crohn’s disease.
This news followed Swissmedic granting orphan drug status for Cx601 in September 2016. The companies said that the marketing authorization application (MAA) for Cx601 has already been under review for the same indication by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Cx601 met primary endpoints
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) locally administered for the treatment of complex perianal fistulas in patients with Crohn’s disease, who have had an inadequate response to at least one conventional or biologic therapy. The Swissmedic filing submission included the Phase III ADMIRE-CD trial data for Cx601. The 24-week data from the trial were published in the Lancet and showed both the primary endpoint and the safety and efficacy profile were met.
Julie Puype, General Manager, Takeda Pharma Switzerland, said that Cx601 could offer another option to current therapiesfor Chron’s, which are often associated with complications and a high failure rate for a disease that is difficult to treat and often leads to pain, swelling, infection and incontinence. Puype further said that the submission to Swissmedic is a key milestone in the commercialization of Cx601.
Complications from Crohn’s disease, such as complex perianal fistulas, can have a severe impact on the lives of those affected, said Dr. María Pascual, VP of Regulatory Affairs and Corporate QA at TiGenix. “This submission by our partner Takeda reflects our joined continued efforts to make Cx601 available to patients and physicians beyond the European Union,” Pascual noted.