Cogan syndrome is a rare autoimmune vasculitis that mainly affects the eyes and inner ears. It is characterized by interstitial keratitis (eye inflammation causing pain, redness, and blurred vision) and audiovestibular symptoms such as hearing loss, dizziness, and balance problems. Some patients also develop systemic vasculitis, which may involve large vessels (aortitis) or other organs. The disease usually appears in young adults and can lead to progressive hearing and vision impairment if untreated. According to CHCC 2012, Cogan syndrome is classified as a primary systemic vasculitis of variable vessel size.
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.