Anti-neutrophil cytoplasmic antibody-associated vasculitis
Development and Regulatory status
Jan 19: EMA filing withdrawn. The filing was for conditional authorisation, and at the time of withdrawal the CHMP was of the provisional opinion that the data provided by the company to that point were insufficient to show effectiveness. There were also concerns over the limited safety data and over the choice of starting materials used in manufacture. The Committee was therefore of the opinion that the company had not provided enough data to support the application. In reply, the company has stated that it intends to focus on future submission of a full marketing authorisation: this will be based on the results of the ongoing ADVOCATE study, which is larger and has a longer treatment duration .
Jan 18: Filed in EU using centralised procedure. Is an orphan status drug in EU .
Jun 16: EMA grants Priority Medicines (PRIME) designation to avacopan for treatment of ANCA-associated vasculitis .·
Trial or other data
Dec 16: PIII ADVOCATE trial to evaluate the safety and efficacy of avacopan in 300 US patients with ANCA-associated vasculitis or AAV treated concomitantly with rituximab or cyclophosphamide/azathioprine starts (NCT02994927). The primary endpoints will be remission and sustained remission, assessed at 26 and 52 weeks, respectively, using Birmingham Vasculitis Activity Score. The randomised, double-blind, placebo-controlled trial is designed to enrol approximately 300 patients in the US. Collection of primary outcome data is expected to complete Jun 19 .
Jun 16: ChemoCentryx reported positive top-line results from the PII CLASSIC trial designed to evaluate the safety and efficacy of avacopan, administered at a low or a high dose, in 42 Us and Canadian patients with ANCA-associated vasculitis (NCT02222155) .
Jan 16: PII CLEAR trial met its primary endpoint indicating a significant non-inferiority in Birmingham Vasculitis Activity Score (BVAS) response relative to the standard of care, that assessed the safety and efficacy of CCX 168 (avacopan) in patients with ANCA-associated vasculitis or AAV (NCT01363388). The randomised, double-blind, placebo-controlled, three-step trial enrolled 63 patients in Austria, Belgium, Czech Republic, France, Germany, Hungary, the Netherlands, Poland, Sweden and the UK .·