Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Press Release

TiGenix provides regulatory update on Cx601 EU Marketing Authorization Application procedure

TiGenix
Posted on: 31 Oct 17

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 11th - 14th 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 

 

About TiGenix

TiGenix NV (Euronext Brussels and NASDAQ: TIG) is an advanced biopharmaceutical company developing novel therapies for serious medical conditions by exploiting the anti-inflammatory properties of allogeneic, or donor-derived, expanded stem cells.

TiGenix lead product, Cx601, has successfully completed a European Phase III clinical trial for the treatment of complex perianal fistulas - a severe, debilitating complication of Crohn's disease. Cx601 has been filed for regulatory approval in Europe and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) started in 2017. TiGenix has entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to develop and commercialize Cx601 for complex perianal fistulas outside the U.S. TiGenix' second adipose-derived product, Cx611, is undergoing a Phase I/II trial in severe sepsis - a major cause of mortality in the developed world. Finally, AlloCSC-01, targeting acute ischemic heart disease, has demonstrated positive results in a Phase I/II trial in acute myocardial infarction (AMI). TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain) and Cambridge, MA (USA). For more information, please visit http://www.tigenix.com.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 31/10/2017

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.