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New Avacopan Analysis Sent to FDA After Data Manipulation Allegations
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Fusion42 · 25 July 2026 · Fusion42 review
Amgen has submitted independent data re-analysis to the FDA in an attempt to prevent revocation of avacopan (Tavneos), a vasculitis drug whose pivotal trial data was found to have been manipulated by its original developer ChemoCentryx. The reanalysis shows noninferiority but no longer demonstrates superiority at 52 weeks, and the drug faces additional scrutiny over fatal liver injury cases.
This Wire brief sits within Fusion42's coverage of Digital Health.
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If you're building a rare-disease drug and your pivotal trial data gets audited, independent re-analysis is now the minimum bar to stay on the market—and even then, it may only prove noninferiority, not the superiority your approval rested on. Amgen's fight suggests the FDA will pull approvals based on data manipulation, not just safety.
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1 source · 25 Jul 2026
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