Cardiovascular safety of febuxostat thelancet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thelancet.com Daily Mail and Mail on Sunday newspapers.
FDA Panel Narrowly Backs Avacopan Approval medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
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ChemoCentryx, Inc. (NASDAQ: CCXI)reported the outcome of the United States Food and Drug Administration Arthritis Advisory Committee on avacopan to treat Antineutrophil Cytoplasmic Autoantibody associated vasculitis. In the final segment of the meetingthe committee voted on three questions present by the FDA:
-The Committee vote split 9-9 on the first question, whether the efficacy data support approval of avacopan for the treatment of adult patients with AAV (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)).
-On the second question, the Committee voted 10-8 that the safety profile of avacopan is adequate to support approval of avacopan for the treatment of adult patients with AAV (GPA and MPA).