- The FDA has approved ChemoCentryx Inc's CCXI Tavneos (avacopan) as an adjunctive treatment for anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
- Related: Adcomm Split On FDA Approval For ChemoCentryx's Vasculitis Candidate.
- The approval comes for avacopan in combination with standard therapy. Avacopan is an orally administered selective complement 5a receptor inhibitor.
- ANCA vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels.
- Avacopan is also approved for microscopic polyangiitis and granulomatosis with polyangiitis (the two main forms of ANCA-associated vasculitis) in Japan.
- The regulatory decision in Europe is expected by the end of 2021.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: CCXI stock is up 70.50% at $33.41 during the premarket session on the last check Friday.
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