EU filing of CCX 168 for vasculitis withdrawn.- ChemoCentryx + Vifor Fresenius

ChemoCentryx and Vifor Fresenius Medical Care Renal Pharma announced that in light of the upcoming availability of data from the pivotal Phase III ADVOCATE trial � the largest controlled trial in active anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-associated vasculitis) � they have decided to withdraw the application for Conditional Marketing Authorisation (CMA) of CCX 168 (avacopan) for the treatment of ANCA-associated vasculitis based on Phase II data.

Efforts will now be exclusively directed to file integrated regulatory submissions in 2020 with the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA) for full (unconditional) marketing approval, after the planned release of topline data from the Phase III ADVOCATE clinical trial anticipated already in the fourth quarter of 2019.

�Since pivotal topline data will be available from our global Phase III ADVOCATE trial later this year, we have decided not to proceed with our limited Phase II-based CMA in Europe,� said Thomas J. Schall, President and Chief Executive Officer of ChemoCentryx.