Europe pulls Tavneos over trial integrity concerns

https://www.ema.europa.eu/en/documents/referral/tavneos-article-20-procedure-scientific-conclusions_en.pdf?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz-9a5A20SZYGd8M6Nb1b4vZ-d6og2aCZq4NTj6pOmmp0etKLMXS803RY8RHNly5-2SjlV8UU-VDYjFUI4D6TBJQkdxIVvg&_hsmi=433538757&utm_content=433538757&utm_source=hs_email Europe pulls Tavneos over trial integrity concerns European regulators last week formally revoked the marketing authorization for Tavneos, the vasculitis treatment developed by ChemoCentryx — a company acquired by Amgen for $4 billion. The EMA concluded that the pivotal trial supporting its approval was unreliable, and that the sponsor personnel behind a Phase 3 study for the drug accessed unblinded efficacy data. Regulatory documents show that the EMA’s Committee for Medicinal Products for Human Use said the drug initially failed to demonstrate superiority at 52 weeks — before researchers re-adjudicated nine patients. This shifted the result from being statistically insignificant to significant, ultimately paving the path for approval, the agency said. Last month, NEJM retracted a paper outlining the Tavneos results. https://www.reuters.com/legal/litigation/amgen-submits-new-data-challenge-fdas-proposal-withdraw-tavneos-2026-07-24/?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz-8vPlSbdrxD1TiXXCgdg4Yp48T04RiPySjC01HDXF0RBf3ufNTdE1nBymSTjz6cE7Gj3EJIRKMJRg0VkSAmJ557nEB4iA&_hsmi=433538757&utm_content=433538757&utm_source=hs_email Regulators said the modifications weren’t adequately disclosed and amounted to a serious breach of good clinical practice. The agency also cited reports of fatal liver injury and vanishing bile duct syndrome, concluding that Tavneos’ benefits could no longer be shown to outweigh its risks. Amgen disputes the decision. It’s making a similar case to the FDA after the agency asked the company in January to voluntarily withdraw Tavneos from the U.S. market. A few weeks ago, Amgen submitted real-world evidence and an independent reanalysis of the trial to regulators. https://www.appliedclinicaltrialsonline.com/view/nejm-retracts-tavneos-trial-fda-ema-amgen-drug-market?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz-9liArKFfWvFTUPZX0Jl2OcDna6h08jkGnx6JxuKmsl-5IXyPJWjSLaaUXwCeV7Sx63HTGMgQBOrmR1-fFLAtiQO58Y-Q&_hsmi=433538757&utm_content=433538757&utm_source=hs_email