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CSL Says CHMP Recommends Revocation of TAVNEOS Marketing Authorization in Europe

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CSL (ASX:CSL) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued an opinion recommending the revocation of the European Union marketing authorization for TAVNEOS, following a review of the handling of data in the Phase 3 ADVOCATE clinical trial supporting the product's approval, according to a Monday Australian bourse filing.

The company said it expects to stop new patient initiation in the EU and European Economic Area (EEA) markets pending the European Commission decision, consistent with regulatory guidance.

"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 Bill Mezzanotte, CSL's head of research & development.

TAVNEOS, an in-licensed therapy sold by CSL Vifor affiliates under license in the EU and EEA markets for the treatment of patients with severe, active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis in combination with standard therapies, the filing added.

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