GPA stands for Granulomatosis with PolyAngiitis. It is an ANCA Associated form of vasculitis (AAV) which is a subgroup of small vessel vasculitis . Until 2012 the disease was referred to as Wegener’s disease, Wegener’s Granulomatosis or Morbus Wegener. Dr. Wegener was the pathologist who first recognized the characteristics of this syndrome as a separate disease and published an important paper about it. GPA is most common form of AAV.
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.
