EMA accepts application of avacopan for the treatment of patients with vasculitis.-Vifor Fresenius Medical Care Renal Pharma + ChemoCentryx.

Vifor Fresenius Medical Care Renal Pharma and ChemoCentryx, Inc. announced a significant milestone in their Kidney Health Alliance : ChemoCentryx's application for avacopan in the treatment of patients with anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis) for regulatory review of its Conditional Marketing Authorization (CMA) application was accepted by the European Medicines Agency (EMA). The EMA's Committee for Medicinal Products for Human Use (CHMP) will now start to assess the CMA application. Under the terms of its kidney health alliance with VFMCRP, ChemoCentryx will receive a milestone payment triggered by this validation of the avacopan CMA application by the EMA.

In a randomized, double-blind, placebo-controlled Phase II study in ANCA vasculitis patients, known as the CLEAR trial, avacopan demonstrated that blocking C5aR at the terminal effector pathway of the complement cascade provides therapeutic efficacy and a favorable risk/benefit profile with a rapid onset of action. Avacopan is currently being studied in the pivotal Phase III ADVOCATE trial for the treatment of ANCA vasculitis and is on track to complete enrollment by mid-2018.