ChemoCentryx, Inc. and Vifor Fresenius Medical Care Renal Pharma Ltd. announced that in light of the upcoming availability of data from the pivotal Phase III ADVOCATE trial – the 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 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. Avacopan is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR. Avacopan is in Phase III development for the treatment of anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (ANCA-associated vasculitis). In clinical studies to date, avacopan was shown to be safe, well tolerated and provided effective control of the disease while allowing elimination of high-dose steroids, part of the current standard of care. ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for ANCA-associated Vasculitis, C3G and atypical hemolytic uremic syndrome (aHUS). The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G.