FDA Arthritis Advisory Committee split over New Drug Application application for avacopan for treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis

Data were reviewed from a phase 3 trial and 2 phase 2 trials of this first-in-class, oral agent that blocks C5aR receptor for pro-inflammatory complement system fragment, C5aq, on inflammatory cells. Committee were split over whether data provided substantial evidence of efficacy

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Biospace Inc.