ChemoCentryx/Vifor Change Tack On EU Avacopan Filing

25 Jan 2019

ChemoCentryx and Vifor Fresenius have changed their conditional marketing authorization application for avacopan to a full MAA in the EU after it emerged that data from the ADVOCATE study will be more comprehensive than expected.

Exchange — The EU avacopan CMA application has been swapped to a full MA. • Source: Shutterstock

ChemoCentryx Inc. and its marketing partner Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) are withdrawing their EU application for a conditional marketing authorization for avacopan in the treatment of ANCA-associated vasculitis, some nine months after the CMA was filed with the European Medicines Agency.

Instead the companies say they will work towards submitting a full MA application in 2020 because the topline data from...