The European Medicines Agency (EMA) has started a review of Tavneos® (avacopan), a medicine used to treat ANCA-associated vasculitis, including GPA and MPA.
This review is not due to new safety concerns or side effects. Instead, it relates to questions about how some data from the main clinical study were collected or analysed. The EMA is re-examining the evidence to confirm that the original conclusions remain valid.
Importantly, this review does not affect patients, and there is no indication that the UK Medicines and Healthcare products Regulatory Agency (MHRA) is carrying out a similar review.
We are sharing this update for transparency and will continue to monitor developments. We will let you know if there are any changes.
For more information, please read the article on Vasculitis International’s website:
EMA starts Review Tavneos® – Vasculitis International