Aust. HC Bulletin: CSL AU - EMA Recommends Revocation of Tavneos Authorization

研报英文原文证据摘录

Aust. HC Bulletin: CSL AU - EMA Recommends Revocation of Tavneos Authorization

Australia | Healthcare EquityJuneResearch27, 2026

Aust. HC Bulletin: CSL AU - EMA

Recommends Revocation of Tavneos

Authorization

We summarise newsflow snippets that are of interest regarding the

Australian Healthcare stocks under our coverage.

EMA recommends revocation of authorization for Tavneos. Vifor Fresenius Medical

Care Renal Pharma (VFMCRP) and CSL (CSL AU, Hold, PT A$108) announced that the

European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has

recommended the revocation of the European Union marketing authorisation for Tavneos

(avacopan). The CHMP opinion has been provided to the European Commission (EC), and

a final decision by the EC is expected shortly. If this recommendation is confirmed by the

European Commission, Tavneos will no longer be authorised in the EU.

CSL Vifor holds the rights to commercialise Tavneos (avacopan) outside the United States.

Vifor Fresenius Medical Care Renal Pharma entered a licence agreement granting rights to

commercialise Tavneos outside the US; this commercialisation is carried out by CSL Vifor in

those territories.

JEF view – we continue to forecast a 50% decline in Tavneos revenues in FY27E. As a result

of this news, CSL has stated that mo new patients will be treated with Tavneos in the EU and

the European Economic Area. We believe the majority of Tavneos revenues for CSL come from

sales in the EU. In FY25, Tavneos sales for CSL were US$112m, or 0.7% of CSL Group revenue.

We continue to assume a 50% decline in Tavneos revenues in FY27E.

Background: European Medicines Agency (EMA) CHMP Feb. 2026 review of Tavneos

following questions regarding data integrity of Advocate study. EMA's human medicines