TiGenix provides regulatory update on Cx601 EU Marketing Authorization Application procedure
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31 oktober 2017 07:00
PRESS RELEASE
TiGenix provides regulatory update on Cx601 EU Marketing Authorization Application procedure
Leuven (BELGIUM) - October 31, 2017, 7:00h CET - 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 , today announces that it provided an Oral Explanation of its responses to the Cx601 Marketing Authorization (MA) Application Day 180 List of Outstanding Issues (LoOI) during the meeting of the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) on October 30, 2017.
An Oral Explanation is part of the MA Application procedure for many novel orphan drugs. TiGenix is confident it provided detailed and clarifying responses to the CAT, which may lead to an opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) at its meeting on 11 th - 14 th December 2017.
The CAT is the EMA's specialised scientific committee for advanced therapy medicinal products (ATMP) such as gene or cell therapies. The committee's main responsibility is to prepare a draft opinion on each ATMP application submitted to the EMA, before the CHMP adopts a final opinion on the marketing authorisation of the medicine concerned. Prior to any adoption of a CAT opinion, MA applicants are normally invited to the CAT plenary meeting to explain positions made in the responses to the Day 180 LoOI.
TiGenix has submitted an MA Application 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. The application was supported by positive 24 and 52 week Phase III data from the ADMIRE-CD trial. Cx601 has been licensed to Takeda for the exclusive development and commercialization outside of the U.S.
For more information
Claudia Jiménez
Senior Director, Investor Relations and Communications
Tel: +34918049264
Claudia.jimenez@tigenix.com