Posted by Michael Wonder on 25 Jan 2019
ChemoCentryx announces withdrawal of Phase II-based conditional marketing authorisation application for ANCA-associated vasculitis in Europe
24 January 2019 - Companies plan to file for full marketing approval to EMA and FDA in 2020.
ChemoCentryx and Vifor Pharma today 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 of 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 EMA and United States FDA for full (unconditional) marketing approval, after the planned release of top-line data from the Phase III ADVOCATE clinical trial anticipated already in the fourth quarter of 2019.
