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ChemoCentryx Announces Filing of Amendment to NDA Submission and Extension of the PDUFA Review Period for Avacopan in the Treatment of ANCA-Associated Vasculitis
SAN CARLOS, Calif., July 06, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that, following consultations with the U.S. Food and
About this update from Chemocentryx Inc.
[{"type":"text","content":"SAN CARLOS, Calif., July 06, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that, following consultations with the U.S. Food and Drug Administration (FDA), it filed an amendment to its New Drug Application (NDA) for avacopan for the treatment of Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis, addressing points raised during the FDA Advisory Committee meeting on May 6, 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 October 7, 2021. 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. “We appreciate the opportunity to put additional data and information before the Agency, information which we believe addresses many of the issues raised at the Advisory Committee meeting,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “We look forward to continuing discussions with the Agency.” 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. About ADVOCATE and ANCA-Associated VasculitisThe ADVOCATE trial of avacopan was a global, randomized, double-blind, active-controlled, double-dummy Phase III trial of 331 patients with ANCA-associated vasculitis in 20 countries. Eligible study subjects were randomized to receive avacopan plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate) or study-supplied oral prednisone plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate). Subjects in both treatment groups could also receive non-protocol glucocorticoids if needed. ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway fur...