[{"orgOrder":0,"company":"Amgen Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ChemoCentryx Announces FDA Acceptance of the Avacopan New Drug Application (NDA) for the Treatment of ANCA-Associated Vasculitis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"CSL Vifor","sponsor":"Amgen Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VFMCRP and ChemoCentryx Announce European Medicines Agency has Accepted to Review the Marketing Authorization Application for avacopan","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Amgen Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ChemoCentryx Announces Plenary Session at ACR Convergence 2020 to Highlight Data from ADVOCATE Phase III Trial in ANCA-Associated Vasculitis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Roche\u2019s Enspryng Leads Latest CHMP Recommendations","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]
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Leading those recommendations is Roche’s Enspryng (satralizumab), which received a positive opinion for the treatment of the rare autoimmune disease neuromyelitis optica spectrum disorders (NMOSD).
The study showed that avacopan was as effective as prednisone therapy in bringing patients into remission by 26 weeks, and superior to prednisone for sustained remission after 52 weeks.
If approved, avacopan would be the first orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis.
The NDA included data from the global, Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group.