FDA Advisory Committee Narrowly Supports Approval of Avacopan

FDA Advisory Committee Narrowly Supports Approval of Avacopan

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FDA Advisory Committee Narrowly Supports Approval of Avacopan

A committee of the U.S. Food and Drug Administration (FDA) — which provides the agency with non-binding recommendations from independent medical experts — has narrowly supported the approval of avacopan for the treatment of ANCA-associated vasculitis (AAV). In the final segment of a public meeting, the committee voted a 9–9 split on whether the efficacy data support approval of avacopan and 10–8 that the therapy’s safety profile adequately supported approval. In a third question, the…

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