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ChemoCentryx/Vifor Change Tack On EU Avacopan Filing

 
• By Ian Schofield

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.

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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 the Phase III ADVOCATE trial will be much more powerful...

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