Anti-C1q vasculitis, also called hypocomplementemic urticarial vasculitis syndrome (HUVS), is a rare small-vessel vasculitis linked to autoantibodies against C1q, a protein of the complement system. It typically presents with chronic hives (urticaria) that last more than 24 hours and leave bruising or skin discoloration. Other common features include joint pain, eye inflammation, and sometimes lung or kidney involvement. Low complement levels in the blood are characteristic. HUVS is considered a primary immune complex–mediated vasculitis in the CHCC 2012 classification, but it can overlap with systemic autoimmune diseases such as lupus.
Vasculitis International is pleased to extend its warmest congratulations to the Vasculitis Foundation (VF) on the occasion of its 40th anniversary. On behalf of the
Vasculitis International has published its position statement on the ongoing regulatory review of TAVNEOS® (avacopan) — and warns that data integrity and risk/benefit analysis are two very different issues and must not be treated as one, when taking action. Otherwise the patient pays for science failure.
The FDA has moved from a review to a formal proposal to withdraw approval of Tavneos in the United States.
This is a more serious step than a review, but it is still not a final decision.
In Europe, the EMA review is still ongoing. No conclusions have been reached yet, and Tavneos is still available.