FDA accepts ChemoCentryx’s avacopan application for blood vessel inflammation

The FDA has accepted ChemoCentryx’s (NASDAQ:CCXI) New Drug Application (NDA) for avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of ANCA-Associated Vasculitis and has set July 7, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date for the avacopan NDA.

The FDA also indicated that it may hold an advisory committee meeting to discuss the application per guidelines for new molecular entities.

ANCA-associated vasculitis is a group of disorders characterized by destruction and inflammation of small vessels.

https://seekingalpha.com/news/3614931-fda-accepts-chemocentryxs-avacopan-application-for-blood-vessel-inflammation