Anti-GBM vasculitis, also known as Goodpasture’s disease, is a rare small-vessel vasculitis caused by antibodies targeting the glomerular basement membrane (GBM) in the kidneys and sometimes the lungs. It typically presents with rapidly progressive glomerulonephritis and, in many cases, pulmonary hemorrhage. When both organs are involved, the condition is often called Goodpasture’s syndrome. It is classified in the CHCC 2012 system as an organ-specific autoimmune vasculitis. The illness can be severe and rapidly progressive, requiring early recognition.
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.