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.
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...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
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<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
