CSL faces EU revocation of TAVNEOS authorisation, $145m in FY26 sales at risk

• CSL Limited (ASX:CSL) says Europe’s medicines regulator has recommended revoking the EU marketing authorisation for TAVNEOS (avacopan)
• CSL expects to stop starting new TAVNEOS patients in EU and EEA markets and forecasts about $145 million in FY26 sales revenue from the drug
• The company says it will follow the regulatory process, manage treatment transitions for ANCA‑associated vasculitis patients, and update investors on any impairment at full‑year results

CSL Limited (ASX:CSL) has reported that the European Medicines Agency’s CHMP has issued an opinion recommending the revocation of the EU marketing authorisation for TAVNEOS (avacopan), an in‑licensed therapy sold in EU and EEA markets by CSL Vifor affiliates.

The recommendation follows a CHMP review under Article 20 of data handling in the pivotal Phase 3 ADVOCATE trial that supported TAVNEOS’ original approval, and comes after CSL’s acquisition of Vifor Pharma, which had entered the licence agreement for the drug in 2016.

“While we are disappointed in the outcome of the Article 20 procedure, we will respect the regulatory process and are committed to implementing it in full,” said CSL Head of Research and Development Dr Bill Mezzanotte.

CSL says the European Commission will now review the CHMP opinion and issue a final decision in due course, and pending that decision the company expects to cease initiating new TAVNEOS patients in EU and EEA markets, in line with regulatory guidance.

The company expects FY26 sales revenue from TAVNEOS to be about $145 million and has told investors it will provide further detail, including any impairment of TAVNEOS intellectual property, with its 2026 full‑year results in August, noting that the announcement does not alter impairment estimates issued on 11 May 2026.

CSL says it remains focused on rare‑disease treatment innovation through its CSL Behring, CSL Seqirus and CSL Vifor businesses, and is working with regulators, clinicians and patient organisations to support compliant treatment transitions for people living with ANCA‑associated vasculitis as the TAVNEOS review progresses.
At the time of reporting the CSL Limited (ASX:CSL) share price was AUD116.08.