Benzinga | Jan 19, 2022 08:40AM EST

ChemoCentryx Reports EU Approval Of Co.'s TAVNEOS For Treatment Of ANCA-Associated Vasculitis; Launch Expected In H1'22

ChemoCentryx, Inc., (NASDAQ:CCXI), today announced that TAVNEOS(r) (avacopan) has been approved within the European Union in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis. This approval follows the U.S. Food and Drug Administration (FDA) approval of TAVNEOS in October 2021. TAVNEOS will receive marketing authorization in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

"European Union approval of TAVNEOS represents the third major global sector to recognize the value of this long-awaited new treatment for the debilitating and often deadly disease of ANCA-associated vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We congratulate our alliance partner, Vifor Pharma, for this significant achievement as we welcome the opportunity for our alliance to serve ANCA patients."

"This is a significant step forward for patients in Europe living with this systemic condition," said Prof. David Jayne, Professor of Clinical Autoimmunity, University of Cambridge. "They will now have available a new class of medication that meets major unmet medical needs in the treatment of ANCA-associated vasculitis."

As part of their Kidney Health Alliance, ChemoCentryx retains all rights for TAVNEOS (avacopan) for orphan and renal diseases in the United States and Vifor Pharma has rights to commercialize avacopan in the rest of the world. Vifor will pay ChemoCentryx royalties in the teens to the mid-20s percent on potential ex-U.S. sales of one aggregate net sales line.