In an earlier update, we told you about the ongoing review of Tavneos (avacopan) by the European Medicines Agency. We also mentioned that the American equivalent — the FDA — was examining similar questions.

There is now an important new development: the FDA has moved from a review to a formal proposal to withdraw approval of Tavneos in the United States.

What does this mean exactly?

Regulatory processes usually follow three stages:

• Review — “We are looking closely at the data”
• Proposal — “We think a change may be needed”
• Decision — “A final conclusion has been reached”

We are now at the second stage. This is a more serious step than a review, but it is still not a final decision.

What is the FDA’s proposal based on?

The FDA has raised concerns on three points: how well the medicine works, the reliability of some of the original study data, and safety signals that were reported after approval.

What is the situation in Europe?

This FDA proposal concerns the United States only and does not change the status of the medicine in other countries. In Europe, the EMA review is still ongoing. No conclusions have been reached yet, and Tavneos is still available.

What to tell your patients?

Do not make any changes to your treatment without first speaking to your doctor or specialist. Your medical team knows your personal situation and is best placed to advise you.

We understand this news may feel worrying, especially if you or someone close to you is using this medicine. We are following developments at both the FDA and EMA closely and will share further updates as soon as new information becomes available.