Avacopan is under clinical development by Amgen and currently in Phase III for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis). According to GlobalData, Phase III drugs for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA Vasculitis) have a 70% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Avacopan’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Avacopan overview

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), systemic lupus erythematosus (SLE), C3 glomerulopathy (C3G) which includes dense deposit disease (DDD), C3 glomerulonephritis (C3GN) and hidradenitis suppurativa. 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) and lupus nephritis.

Amgen overview

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 for the treatment of cardiovascular conditions, oncology/hematology, inflammation, bone health, neurological disorders and nephrology conditions. The company analyzes the difficulties of disease and understands the fundamentals of human biology to develop products harnessing advanced human genetics. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels and through partnerships with other companies. The company has a presence in Asia Pacific, Europe, the Middle East, the Americas and Australia. Amgen is headquartered in Thousand Oaks, California, the US.

For a complete picture of Avacopan’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.