ChemoCentryx and VFMCRP announce European Medicines Agency has accepted to review the AA for avacopan to treat ANCA- associated Vasculitis.

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) Ltd. and ChemoCentryx, Inc., announced that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for avacopan for the treatment of patients with ANCA-associated vasculitis (granulomatosis with polyangitis (GPA) and microscopic polyangiitis (MPA)), a group of rare and severe autoimmune diseases with high need for targeted therapies. If approved, avacopan would be the first orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis. Data from the global pivotal Phase-III ADVOCATE trial demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group. In the trial, the avacopan group also showed significantly lower glucocorticoid toxicity, greater improvement in kidney function and greater improvement in health-related quality of life measures compared to the prednisone group. The EMA will review the application under the centralized marketing authorization procedure. If approved, avacopan would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. Approval is expected H2, 2021.