Posted by Michael Wonder on 07 Jul 2021
ChemoCentryx announces filing of amendment to NDA submission and extension of the PDUFA review period for avacopan in the treatment of ANCA associated vasculitis
6 July 2021 - ChemoCentryx today announced that, following consultations with the U.S. FDA, it filed an amendment to its new drug application for avacopan for the treatment of anti-neutrophil cytoplasmic auto-antibody associated vasculitis, addressing points raised during the FDA Advisory Committee meeting on 6 May 2021.
The FDA has indicated that the filing constitutes a major amendment to the NDA and will result in the setting of a new PDUFA goal date of 7 October 2021.
The new drug application is primarily based on data from the Phase 3 ADVOCATE trial of avacopan for the treatment of anti-neutrophil cytoplasmic auto-antibody associated vasculitis.
On 6 May, 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.
