Kawasaki Disease (KD) (also known as Kawasaki Syndrome) is a rare form of vasculitis which affects children and is characterised by inflammation of the medium sized blood vessels throughout the body.
The coronary arteries (arteries supplying the heart muscle) are the commonest arteries affected.
The main concern in children is that inflammation of the coronary arteries can lead to aneurysms (widening and weakening of the artery wall) and later can lead to narrowing or stenosis reducing the blood supply to the heart.
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.
