First New Treatment in a Decade for ANCA-Vasculitis Approved

Tecartus Granted New Leukemia Indication
October 5, 2021
FDA Approves Novel Treatment for Rare Immune Disorder in Children
October 11, 2021
Tecartus Granted New Leukemia Indication
October 5, 2021
FDA Approves Novel Treatment for Rare Immune Disorder in Children
October 11, 2021

October 8, 2021 – TavneosTM (avacopan – ChemoCentryx) is now U.S. FDA approved for use in adults as an adjunct to standard therapy (including glucocorticoids) to treat severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis [granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)].

  • ANCA-associated vasculitis is a potentially fatal autoimmune condition. It causes the inflammation and destruction of small blood vessels, leading to organ damage and organ failure.
  • Tavneos is the first FDA-approved, orally administered drug in a class known as complement C5a receptor inhibitors.
  • Recommended dosing is 30mg (three 10mg capsules) taken by mouth twice daily with food.
  • Tavneos has launched at a wholesale acquisition cost (WAC) of $14,450 per one-month supply.