Biopharmaceutical company, TiGenix, has submitted responses to the marketing authorisation application for Cx601, a treatment of complex perianal fistulas in Crohn’s disease patients as a first indication.
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Submission of responses to the Committee for Medicinal Products for Human Use (CHMP) Day 180 List of Outstanding Issues (LoOI) is a standard part of the regulatory procedure. Once submitted, and on the 181st day, the European Medicines Agency (EMA) then continues its review of the files after a ‘clock stop’.
For Cx601, day 181 falls at the start of September, which the company reports could trigger the CHMP opinion in October. TiGenix has also confirmed it is confident it will remain on track to receive a marketing authorisation decision this year.
“This submission represents another important step forward in working towards a European approval decision for Cx601 during 2017,” said Dr María Pascual, VP of regulatory affairs and corporate QA of TiGenix. “In parallel, we have advanced the preparations for the start of a global Phase III clinical trial intended to support a future US biologics license application (BLA) with first submissions to regulatory bodies performed. We look forward to providing updates on this dual path over the coming months.”