ChemoCentryx Announces Withdrawal of Phase II-Based Conditional Marketing Authorisation (CMA) Application for ANCA-Associated Vasculitis in Europe, Phase III Advocate Trial Data Release Planned for Q4 2019

Regulatory News:

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ChemoCentryx, Inc. and Vifor Fresenius Medical Care Renal Pharma Ltd., a company of Vifor Pharma Group, today announced that in light of the upcoming availability of data from the pivotal Phase III ADVOCATE trial – the largest controlled trial in active anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-associated vasculitis) – they have decided to withdraw the application for Conditional Marketing Authorisation (CMA) of avacopan for the treatment of ANCA-associated vasculitis based on Phase II data. Efforts will now 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.

“Since pivotal topline data will be available from our global Phase III ADVOCATE trial later this year, we have decided not to proceed with our limited Phase II-based CMA in Europe,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “The pace of the worldwide ADVOCATE trial enrollment was considerably greater than originally anticipated when we applied for the European CMA; which was based on data from our Phase II CLEAR trial comprising 12 week dosing on some 67 patients. Since Phase III ADVOCATE assesses more than 300 ANCA vasculitis patients through 52 weeks of treatment, the imminent comprehensive data set will be much more powerful than those in the CMA application, therefore enabling a more consistent set of filings in Europe and the US. We would like to thank the Rapporteurs and the Committee for Medicinal Products for Human Use (CHMP) for the valuable support and guidance they provided to us as we look forward to topline ADVOCATE data in the fourth quarter this year.”

Stefan Schulze, President of the Executive Committee and Chief Operating Officer of Vifor Pharma Group, commented, “We strongly support the decision to focus on a full Market Authorisation. We believe this will offer regulators and the companies a much clearer view of the performance of avacopan in the treatment of ANCA-associated vasculitis, a group of rare kidney autoimmune diseases that lead to significant morbidity and mortality, and where there is a clear unmet need for safer and more efficacious therapies.”