FDA has proposed to withdraw approval of Tavneos (avacopan) due to concerns about efficacy and data integrity, and Amgen has requested a formal hearing to challenge this decision.
Amgen has engaged the Duke Clinical Research Institute to conduct an independent, blinded re‑analysis of the ADVOCATE trial data that underpinned Tavneos’s approval.
Findings from this independent review are expected to be included in Amgen’s written submissions and could be presented or referenced during the FDA hearing process, though the FDA has suggested new analyses cannot "rescue" the original trial.
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安进(AMGN.US)聘请杜克临床研究所独立复核 力保明星药Tavneos免于退市
FDA Has Recommended Removing Approval for Tavneos (Avacopan)