New Avacopan Analysis Sent to FDA After Data Manipulation Allegations

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.

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