The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for avacopan (ChemoCentryx) for the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
ANCA-associated vasculitis is a systemic disease characterized by the inflammation and destruction of small blood vessels resulting in organ damage and failure. Avacopan is a first-in-class, orally-administered, small molecule designed to selectively block the complement 5a receptor (C5aR) on destructive inflammatory cells such as blood neutrophils.
The NDA includes data from the double-blind, active-controlled phase 3 ADVOCATE trial, which evaluated the efficacy and safety of avacopan in 331 adult patients with ANCA-associated vasculitis. Findings from the study showed that 72.3% of avacopan-treated patients achieved disease remission (as assessed by Birmingham Vasculitis Activity Score) at week 26 compared with 70.1% of prednisone-treated patients, establishing noninferiority of the investigational treatment (P <.0001). At week 52, avacopan demonstrated statistical superiority in sustained remission compared with prednisone (65.7% vs 54.9%, respectively; P =.0066).
The safety profile of avacopan was found to be favorable with fewer serious adverse events reported compared with prednisone.
A Prescription Drug User Fee Act (PDUFA) target date of July 7, 2021 has been set for this application.
For more information visit chemocentryx.com.
ChemoCentryx announces FDA acceptance of the avacopan New Drug Application (NDA) for the treatment of ANCA-associated vasculitis. https://www.globenewswire.com/news-release/2020/09/17/2095212/0/en/ChemoCentryx-Announces-FDA-Acceptance-of-the-Avacopan-New-Drug-Application-NDA-for-the-Treatment-of-ANCA-Associated-Vasculitis.html. Accessed September 17, 2020.