FDA requests Amgen to withdraw Tavneos citing concerns over data interpretation from 2021 approval

The U.S. Food and Drug Administration (FDA) has requested that Amgen withdraw its drug Tavneos from the market, citing concerns over data interpretation issues tied to its 2021 approval. The decision stems from a re-evaluation of years-old clinical trial data related to the drug’s primary endpoint, which played a critical role in securing regulatory approval following a narrowly split advisory committee vote. Tavneos, developed for treating anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, became part of Amgen’s portfolio after its $4 billion acquisition of ChemoCentryx in 2022.

The FDA’s renewed scrutiny focuses on how the original trial results were interpreted and presented during the approval process. At the time, questions arose regarding whether the data sufficiently demonstrated Tavneos’ efficacy in achieving its primary endpoint. Despite these concerns, the advisory committee voted in favor of approval by a slim margin. This latest development could have significant implications for Amgen’s investment in ChemoCentryx and raises broader questions about regulatory oversight and post-market evaluations of approved drugs.

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Date: February 4, 2026

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GOAI