Avacopan is under clinical development by Amgen and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Avacopan’s likelihood of approval (LoA) and phase transition for Churg-Strauss Syndrome took place on 21 Oct 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.
In addition, the same event on 21 Oct 2022 increased Avacopan’s LoA and PTSR for Atypical Hemolytic Uremic Syndrome (Nondiarrhea – Associated Hemolytic Uremic Syndrome), increased PTSR for Glomerulonephritis, increased LoA and PTSR for Hidradenitis Suppurativa, and increased PTSR for Membranoproliferative Glomerulonephritis Type II (Dense Deposit Disease).
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Avacopan Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Avacopan (Tavneos) is a selective immunosuppressant. It is formulated as hard capsules for oral route of administration. Tavneos is indicated for the treatment of patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), the two main types of ANCA-associated vasculitis, a rare and severe autoimmune renal disease with high unmet medical need.
Avacopan (CCX-168) is under development for the treatment of anti-neutrophil cytoplasmic autoantibodies (ANCA)-associated vasculitis and Churg-Strauss syndrome, atypical hemolytic uremic syndrome (aHUS), C3 glomerulopathy (C3G) which includes dense deposit disease (DDD), C3 glomerulonephritis (C3GN) and hidradenitis suppurativa, lupus nephritis. CCX-168 is an orally bioavailable small molecule antagonist of the C5a receptor. The drug candidate is based on the EnabaLink platform. It was also under development for the treatment of IgA nephropathy (Berger's disease).
Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.
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