European Medicines Agency Gives Positive Opinion on TiGenix’s Pediatric Investigation Plan For CD Perianal Fistulas Treatment

European Medicines Agency Gives Positive Opinion on TiGenix’s Pediatric Investigation Plan For CD Perianal Fistulas Treatment
shutterstock_204405208Biopharmaceutical company TiGenix NV, which is currently developing and commercializing novel therapeutics from its proprietary platform of allogeneic, expanded adipose-derived stem cells (eASC's) for inflammatory and autoimmune diseases, announced that it received a positive recommendation for its Pediatric Investigation Plan (PIP), from the Pediatric Committee of the European Medicines Agency (EMA). PIP is focused on the company's locally injected stem cell product Cx601, for the treatment of complex perianal fistulas in patients with Crohn's disease, which is currently in its phase III of clinical development. The recommendation of the PIP will allow the company to fill the EMA new medical product marketing authorization, since it is a requirement for the drug to be used to treat children. After the completion of the PIP, TiGenix NV will receive an additional six months' patent exclusivity for the product. Cx601 already has Orphan Drug status, which was granted by the EMA in 2009 and gave it ten years of market exclusivity from the date of marketing authorization. "We are pleased with the EMA's positive opinion on our PIP for Cx601 which allows us to keep moving towards our filing for marketing authorization for Cx601 in the first half of 2016," explained the VP Regulatory Af
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