CSL halts Tavneos drug sale following EU regulatory setback
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The news: CSL will cease new patient initiations across European Union and European Economic Area (EEA) markets following the Committee for Medicinal Products for Human Use (CHMP) recommendation to revoke the marketing authorisation for its Tavneos drug.
The context: The withdrawal follows the CHMP’s review under Article 20 regarding data handling in the pivotal Phase 3 advocate clinical trial supporting the product’s approval.
Sales revenue from Tavneos for FY26 is projected to be approximately $145 million.
Tavneos is indicated for the treatment of adults with severe ANCA-associated vasculitis, a group of rare autoimmune disorders that cause inflammation and damage to small and medium blood vessels.
What they said: “We recognise this is a difficult moment for the community, as Tavneos has played an important role for patients living with ANCA-associated vasculitis, a life-threatening disease with limited treatment options,” CSL head of research development Bill Mezzanotte said.
“We are working closely with regulatory authorities, healthcare professionals and patient organisations to ensure a compliant and appropriate treatment transition, along with ongoing support for patients,” he added.
The source: ASX
