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Anti-neural granulocytic antibody (ANCA)-associated angiotisitis (AAV) is a class of autoimmune disease characterized by small vascular necrotization inflammation and the presence of ANCA, which can affect the whole system, can be life-threatening in severe cases, and is prone to recurrence after treatment.
pharmaceutical company Chemo Centryx announced today that the U.S. Food and Drug Administration (FDA) has granted Avacopan a new drug application (NDA), an oral, alternative supplement 5a-inhibitor inhibitor used to treat ANCA-related vasculitis.
fda has set July 7, 2021 as the target date for the Avacopan NDA Prescription Drug User Costs Act (PDUFA).
NDA was supported by data from the Global Phase III ADVOCATE trial, which showed that the avacopan group had a statistical advantage in maintaining 52-week mitigation compared to the Pernisson group.
the avacopan group also showed significantly reduced toxicity of glucoticoids, improved kidney function, and improved health-related quality-of-life indicators compared to the Pernisson group.
, the avacopan group shows good security.
ADVOCATE trial is a global, randomized, double-blind Phase III clinical trial in which 331 patients with ANCA-related vasculitis were studied in 20 countries.
Eligible subjects were randomly assigned to receive avacopan Unilphate or cyclophosphamide (followed by thiopental/mycophenolate) or Pernisun Unilphate or cyclophosphamide (followed by thiopental/mycophenolate).
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