4 January 2018 - Conditional marketing authorisation application for treatment of patients with ANCA-associated vasculitis validated for start of procedure by EMA.

Vifor Fresenius Medical Care Renal Pharma and ChemoCentryx announced today 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 authorisation (CMA) application was accepted by the EMA. The EMA's CHMP will now start to assess the CMA appplication. Under the terms of its kidney health alliance with Vifor Fresenius Medical Care Renal Pharma. ChemoCentryx will receive a milestone payment triggered by this validation of the avacopan CMA application by the EMA.

Avacopan is an orally-administered small molecule that is a highly selective inhibitor of the terminal effector complement C5a receptor (C5aR). Avacopan is currently in late-stage clinical development for the treatment of orphan and rare renal diseases, including ANCA vasculitis. 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 favourable 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 enrolment by mid-2018. 

Read Vifor Fresenius Medical Care Renal Pharma press release