The European Medicines Agency has recommended withdrawing marketing authorization for Tavneos, an inflammatory disorder drug co-marketed by Amgen and Vifor, concluding that its benefits no longer demonstrably outweigh its risks. The decision by the Committee for Medicinal Products for Human Use (CHMP) follows a similar move by the U.S. Food and Drug Administration, which has proposed pulling the drug from the American market over safety signals and allegations of clinical trial data manipulation.
The CHMP’s review, initiated in late January, determined that the pivotal Advocate study was conducted in breach of good clinical practice principles. The committee found that data submitted during the original marketing authorization application were “incorrect and misleading” and can no longer be relied upon to prove efficacy. Additionally, post-marketing data and post-hoc analyses were deemed insufficient to establish the drug’s benefits.
Tavneos (avacopan) is an oral C5a receptor inhibitor developed by ChemoCentryx, which Amgen acquired in 2022. It was approved as an adjunct therapy for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, a group of rare autoimmune diseases causing blood vessel inflammation and organ damage. While standard treatment relies heavily on corticosteroids—which carry significant long-term toxicity—Tavneos was designed to reduce steroid dependence.
In Europe, Vifor Fresenius Medical Care Renal Pharma, a CSL Limited subsidiary, holds commercial rights outside the U.S. and Japan. The CHMP has advised against initiating new patients on the therapy and recommended that current patients be transitioned to alternative treatments. The European Commission must formally adopt the committee’s opinion before the withdrawal takes legal effect.
The FDA’s concerns were triggered in part by reports of severe liver injury, primarily from Japan, where Kissei Pharmaceutical holds sublicensed rights. In April, the FDA proposed withdrawal and offered Amgen a hearing; the company has requested one, with a submission deadline now extended to July 29.
Amgen stated it remains “deeply concerned” about patient access and maintains that Tavneos has a favorable benefit-risk profile supported by over 20 real-world studies. The company says it continues to engage with the FDA as the U.S. regulatory process proceeds.
Photo: Yuriko Nakao/Bloomberg, via Getty Images
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