BioCentury
ARTICLE | Clinical News

ChemoCentryx, Vifor Fresenius to seek full approval of avacopan next year

January 25, 2019 8:54 PM UTC

ChemoCentryx Inc. (NASDAQ:CCXI) and partner Vifor Fresenius Medical Care Renal Pharma Ltd. voluntarily withdrew a conditional marketing authorization (CMA) application in the EU for avacopan (CCX168) to treat antineutrophil cytoplasmic antibody associated vasculitis, since Phase III data will soon be available. The CMA was based on Phase II data.

ChemoCentryx and Vifor Fresenius plan to instead submit regulatory submissions for full marketing approval in the EU and U.S. next year after reporting top-line data in 4Q19 from the Phase III ADVOCATE trial of avacopan in the indication...