Posted by Michael Wonder on 17 Sep 2020
ChemoCentryx announces FDA acceptance of the avacopan new drug application for the treatment of ANCA associated vasculitis
17 September 2020 - FDA sets PDUFA goal date of 7 July 2021.
ChemoCentryx today announced that the U.S. FDA has accepted the Company’s new drug application for avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of ANCA associated vasculitis and has set 7 July 2021 as the Prescription Drug User Fee Act goal date for the avacopan new drug application.
Avacopan is a first-in-class, orally administered therapy that employs a novel, highly targeted mode of action in the treatment of ANCA associated vasculitis.
