FDA approves avacopan for ANCA-associated vasculitis

Thorley, Jennifer

doi:10.1016/s2665-9913(21)00391-x

Cited by 7 publications

(4 citation statements)

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“…1 In October 2021, avacopan was approved by the Food and Drug Administration (FDA) as an adjunct to treatment alongside glucocorticoids and other immunosuppressants for MPA and GPA. 3 The purpose of this review is to assess the safety, efficacy, and clinical application of avacopan in the treatment of ANCA-associated vasculitis compared with glucocorticoids.…”

Section: Introductionmentioning

confidence: 99%

Avacopan for the Treatment of Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

et al. 2023

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Objective: To review the safety and efficacy of avacopan for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Data Sources: A systematic review of the literature was performed using the terms avacopan OR tavneos OR CCX168 OR ANCA-associated vasculitis in PubMed and Google Scholar. Articles between January 2016 and January 2023 were considered for inclusion. Bibliographies and ClinicalTrials.gov were also searched for completion. Study Selection and Data Extraction: Relative English language and human studies related to pharmacology, clinical trials, and safety were included. Data Synthesis: The 52-week ADVOCATE and 12-week CLEAR clinical trials evaluated the safety and efficacy of avacopan. The remission rate was 65.7% and 54.9% in the avacopan and placebo group, respectively, in the ADVOCATE trial. The Birmingham Vasculitis Activity Score improved by ≥50% in 86.4% of avacopan treated patients and 70% of prednisone treated patients in the CLEAR trial. Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs: Glucocorticoids in combination with cyclophosphamide, azathioprine, and/or rituximab have been a mainstay of ANCA-associated vasculitis treatment. However, short- and long-term medication-related adverse effects risk negative outcomes for patients. Avacopan may provide equivalent to better treatment with fewer side effects due to a reduction, if not elimination, of glucocorticoids. Conclusions: Avacopan used in isolation or combination is safe and effective for ANCA-associated vasculitis.

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Section: Introductionmentioning

confidence: 99%

Avacopan for the Treatment of Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

et al. 2023

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“…Avacopan, pod nazwą leku Tavneos, to pierwszy w swojej klasie lek zatwierdzony w zapaleniu naczyń związanym z ANCA jako głównym wskazaniem. 5 Ten doustnie stosowany środek stanowi dodatek do standardowej terapii w dwóch głównych postaciach zapaleń związanych z ANCA -mikroskopowym zapaleniu naczyń oraz ziarniniakowatości z zapaleniem naczyń. 5 Tavneos to pierwszy od dekady lek zatwierdzony z takim wskazaniem.…”

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“…5 Ten doustnie stosowany środek stanowi dodatek do standardowej terapii w dwóch głównych postaciach zapaleń związanych z ANCA -mikroskopowym zapaleniu naczyń oraz ziarniniakowatości z zapaleniem naczyń. 5 Tavneos to pierwszy od dekady lek zatwierdzony z takim wskazaniem. 5 W Unii Europejskiej został on dopuszczony do obrotu w dniu 11 stycznia 2022 r. 6…”

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The complement system and its role in the treatment of ANCA-associated vasculitis

Rybak

Dudek

Czarnota

et al. 2022

J Educ Health Sport

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Objective: This study aimed to evaluate the role of the complement system in a therapy of the ANCA- associated vasculitis. Methods and materials: A literature search was conducted in the PubMed MEADLINE database of medical publications using the following keywords: the complement system, AVV, C5a inhibitor, avacopan Results: The complement system is a crucial part of the human immune system. Its cascade is involved in the pathogenesis of many disease entities, especially those with an inflammatory response. As anaphylatoxin, this is especially true of the C5a protein. C5a receptors are distributed mainly on tissue inflammatory cells, e.g. macrophages, mast cells, and endothelial cells. Therefore a C5a receptor inhibitor may reduce the inflammatory response of the body. This mechanism is used by the Avacopan, a newly approved drug for the treatment of ANCA-associated vasculitis as the main indication. Tavneos (avacopan) was only introduced in the UE in January 2022, as the first new drug to treat AVV in over a decade. Conclusion: The C5a receptor inhibitor – Avacopan might be the future of a glucocorticoids-free or glucocorticoids – low dose therapy of ANCA-associated vasculitis. As the ADVOCATE clinical trial shows, Avacopan was neither superior, nor inferior to prednisone tamper with respect to sustained remission at 26 weeks, but proved to be superior with sustaining remission at 52 weeks. All the patients received rituximab or cyclophosphamide as a form of therapy. Keywords: the complement system; C5a receptor inhibitor, AVV; Avacopan

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Avacopan as an add-on therapy for ANCA-associated vasculitis: a pharmacological overview

Tesar,

Hartinger,

Hruskova

2024

Expert Review of Clinical Pharmacology

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FDA approves avacopan for ANCA-associated vasculitis

Cited by 7 publications

References 0 publications

Avacopan for the Treatment of Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

Avacopan for the Treatment of Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

The complement system and its role in the treatment of ANCA-associated vasculitis

Avacopan as an add-on therapy for ANCA-associated vasculitis: a pharmacological overview

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