THOUSAND OAKS (dpa-AFX) - Vifor Fresenius Medical Care Renal Pharma and CSL (CSL.AX) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the revocation of the European Union marketing authorisation for TAVNEOS. The CHMP recommendation is based on a review of TAVNEOS under an Article 20 non-pharmacovigilance procedure that was initiated due to concerns related to data handling in the pivotal Phase 3 ADVOCATE trial.
TAVNEOS is a treatment for adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis. It was developed by ChemoCentryx and is commercialised outside the US and in selected countries by CSL, its affiliates and partners pursuant to a collaboration and license agreement between Vifor Fresenius Medical Care Renal Pharma Ltd. and ChemoCentryx. Amgen acquired ChemoCentryx in 2022.
CSL shares are trading at A$114.87 on the Australian Securities Exchange, down 2.36%.
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