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FDA Advisors Split on New Drug for Vasculitis

May 7, 2021


Members of an FDA advisory panel were sharply divided as to whether avacopan, an oral small molecule inhibitor of the C5a receptor, was sufficiently safe and effective for treating antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

As to whether the efficacy data supported approval of the drug, the FDA’s Arthritis Advisory Committee was split 9 to 9; on whether the safety data were sufficient, the vote was 10 in favor and 8 against; and on whether the benefit-risk profile supported approval, again the vote was 10 in favor and 8 against.

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