Amendment filed to FDA for CCX 168 in vasculitis and PUDFA goal date delayed.- ChemoCentryx

The NDA is primarily based on data from the Phase III ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis. On May 6, the FDA’s Arthritis Advisory Committee voted 9-9 on whether the efficacy data support approval of avacopan, 10-8 that the safety profile of avacopan is adequate to support approval, and 10-8 that the benefit-risk profile is adequate to support approval of avacopan at the proposed dose of 30 mg twice daily.

Comment:The Marketing Authorization Application (MAA) for avacopan in the treatment of ANCA-associated vasculitis was validated by the European Medicines Agency (EMA) in November 2020, and the Japanese New Drug Application was accepted for review by the Japanese Pharmaceuticals and Medical Device Agency in February 2021.