Takayasu Arteritis (TA) is an inflammatory disease of the large arteries. TA particularly affects the aorta (the main artery taking blood from the heart to the rest of the body), and the pulmonary artery (which sends blood to the lungs). The major arteries that arise from the aorta may also be affected. These include the subclavian arteries that supply the arms, renal arteries to the kidneys, coronary arteries in the heart and carotid arteries in the head and brain. (see illustrations below)
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.
