Avacopan

Unassigned

New Medicines

Anti-neutrophil cytoplasmic antibody-associated vasculitis

Information

New molecular entity
ChemoCentryx
ChemoCentryx

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase III Clinical Trials

Jan 18: Filed in EU using centralised procedure. Is an orphan status drug in EU [4].


Jun 16: EMA grants Priority Medicines (PRIME) designation to avacopan for treatment of ANCA-associated vasculitis [3].

Category

Small molecule, complement C5a receptor inhibitor
UK incidence is 23.1 per million person-years [1].
Anti-neutrophil cytoplasmic antibody-associated vasculitis
Oral

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 [2].


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) [3].


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 [3].