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TiGenix announces approval of trade name for lead development candidate Cx601 in Europe

TiGenix NV (Euronext Brussels and NASDAQ: TIG), an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop novel therapies for serious medical conditions, announces today that the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has approved the company’s proposed trade name Alofisel for its proprietary investigational compound Cx601, a treatment for complex perianal fistulas in patients with Crohn’s disease.
The trade name Alofisel, a registered trademark owned by TiGenix, will be used from now onwards in the ongoing centralized drug approval process of Cx601 with the EMA, covering all 28 member states of the EU, plus Norway, Iceland and Lichtenstein, as well as from the time of launch following marketing authorization.
TiGenix has also received approval from the United States Adopted Names (USAN) Council and the International Nonproprietary Names (INN) Expert Group at the World Health Organization (WHO) for the use of the nonproprietary name darvadstrocel for Cx601. Darvadstrocel will be included in the forthcoming list of recommended INNs published by the WHO. INNs are simple, informative and unique nonproprietary names for drugs based on pharmacological and/or chemical relationships to allow for clear identification and communication among health professionals.
TiGenix has submitted a Marketing Authorization (MA) Application for Alofisel to the EMA for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. A CHMP opinion is expected in 2017.