Tavneos (avacopan) / Amgen 
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 5 Diseases   7 Trials   7 Trials   708 News 


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  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Journal:  Expert Perspective: Management of ANCA-Associated Vasculitis. (Pubmed Central) -  Jul 31, 2022   
    Certain features, including history of previous relapse, the presence of ANCA directed against proteinase 3, and diagnosis of granulomatosis with polyangiitis favor prolonged remission maintenance therapy. The interval between rituximab doses can usually be lengthened over time during the maintenance phase.
  • ||||||||||  Review, Journal:  Complement System as a New Target for Hematopoietic Stem Cell Transplantation-Related Thrombotic Microangiopathy. (Pubmed Central) -  Jul 29, 2022   
    Thus, it seems reasonable to propose complement inhibition therapy only to those patients exhibiting a clear complement activation according to the available biomarkers. Several agents are now available to inhibit complement activity: two drugs have been successfully used in TA-TMA, particularly in pediatric cases (eculizumab and narsoplimab) and others are at different stages of development (ravulizumab, coversin, pegcetacoplan, crovalimab, avacopan, iptacopan, danicopan, BCX9930, and AMY-101).
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal:  Complement Inhibition in ANCA-Associated Vasculitis. (Pubmed Central) -  Jul 27, 2022   
    Avacopan (C5a receptor inhibitor) was demonstrated to have at least similar efficacy and better safety (in terms of corticosteroid-related adverse events) compared with high-dose corticosteroids in the induction treatment of AAV. Other modes of the inhibition of alternative complement pathway are currently tested in AAV or could be considered on the basis of the experience in other glomerular diseases.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
    Review, Journal:  The Complement System and ANCA Associated Vasculitis in the Era of Anti-Complement Drugs. (Pubmed Central) -  Jul 13, 2022   
    Recently accumulated evidence has shown that C5a produced by the complement alternative pathway primes neutrophils, which in turn activate the complement alternative pathway, leading to the pathogenesis of AAV. Avacopan (CCX168), a C5aR antagonist was shown to be effective against AAV, and it has been a novel therapeutic option, becoming a novel anti-complement drug to modulate inflammatory diseases.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
    Biomarker, Journal, Tumor microenvironment, Myeloid-derived suppressor cells:  Suppressing MDSC Infiltration in Tumor Microenvironment Serves as an Option for Treating Ovarian Cancer Metastasis. (Pubmed Central) -  Jul 13, 2022   
    Application of C5aR antibody or inhibitor (CCX168) inhibits MDSC recruitment and restores the suppression of tumorigenesis and metastasis in vivo. Our study reveals that suppression of ovarian cancer metastasis can be achieved by targeting MDSC infiltration in TME through disrupting LncOVM-PPIP5K2-complement axis, providing an option for treating ovarian cancer patients.
  • ||||||||||  Retrospective data, Review, Journal:  Biologics and Small Molecule Inhibitors for Treating Hidradenitis Suppurativa: A Systematic Review and Meta-Analysis. (Pubmed Central) -  Jun 25, 2022   
    Our study reveals that suppression of ovarian cancer metastasis can be achieved by targeting MDSC infiltration in TME through disrupting LncOVM-PPIP5K2-complement axis, providing an option for treating ovarian cancer patients. Adalimumab and bimekizumab are the only two biologics effective in achieving HiSCR with acceptable safety profile, whereas adalimumab is the only biologic effective in achieving DLQI 0/1.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
    NCA VASCULITIS : THE ROLE OF COMPLEMENT INHIBITION (NIKOS SKALKOTAS) -  May 25, 2022 - Abstract #AUTO2022AUTO_299;    
    Phase I, II, and III findings with emphasis on the efficacy, and safety of Avacopan, a new oral competitive inhibitor that interferes with the binding of C5a to C5aR1 (CD88) will be reviewed...It is expected that approval in other countries will follow soon. At present, complement inhibition is also investigated for the treatment of complement component 3 glomerulopathy, severe COVID-19 infections, hidradenitis suppurativa, lupus nephritis and IgA nephropathy.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    ANTI-COMPLEMENT THERAPY IN ANCA-ASSOCIATED VASCULITIS AND BEYOND (MC2 HALL) -  May 25, 2022 - Abstract #AUTO2022AUTO_93;    
    Compared to glucocorticosteroid-based scheme, the Avacopan regimen combined with CYC or RTX was non-inferior at week 26 and superior at week 52 in sustaining remission Conclusions The results of these trials opened new therapeutic prospects for patients with AAV. The possible indications for Avacopan in specific subsets of patients with AAV, and the putative implications in the treatment of other immune-mediated kidney diseases (e.g., C3 GN, lupus nephritis, membranous nephropathy, IgA nephropathy, and others) will be extensively examined.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
    INCIDENCE OF INFECTIONS IN THE AVACOPAN GROUP VERSUS PREDNISONE GROUP IN ANCA-ASSOCIATED VASCULITIS, RESULTS FROM THE PHASE 3 ADVOCATE STUDY (Hall S03) -  May 5, 2022 - Abstract #ERAEDTA2022ERA_EDTA_587;    
    Infections in the ADVOCATE trial of ANCA-associated vasculitis CONCLUSION In the ADVOCATE trial, the mean dose of GCs from all sources was 63% lower in the avacopan group than the prednisone group (1349 versus 3655 total mg, respectively). The avacopan group had a numerically lower incidence of infections, including serious, life-threatening, fatal and serious opportunistic infections compared with the prednisone group.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
    Review, Journal:  ANCA Associated Vasculitis Subtypes: Recent Insights and Future Perspectives. (Pubmed Central) -  Apr 29, 2022   
    This review describes emerging treatment regimens, including evidence for plasma exchange in severe disease and the inhibitor of the complement C5a receptor (C5aR) inhibitor, Avacopan. Lastly, patient reported outcomes are key secondary outcomes in randomised controlled trials and increasingly clinical practice, we report development in disease specific and glucocorticoid-specific PROs.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Actemra IV (tocilizumab) / Roche, JW Pharma, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal:  Perspectives of JAK Inhibitors for Large Vessel Vasculitis. (Pubmed Central) -  Apr 19, 2022   
    More recently, avacopan, an inhibitor of the complement 5a receptor, was shown to have high efficacy in remission induction against AAV...In contrast, in large vessel vasculitis (LVV), including giant cell arteritis and Takayasu arteritis, tocilizumab, an IL-6 receptor antagonist, was shown to be effective in suppressing relapse and has steroid-sparing effects...Then, the pathophysiology of LVV is updated, and a rationale for treating LVV with JAK inhibitors is provided with a brief introduction of our preliminary results using a mouse model. Finally, we discuss the newly raised safety concerns regarding JAK inhibitors and future perspectives for treating LVV.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Expansion of myeloperoxidase (MPO)-specific IgM B cells in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (Congress Hall D1) -  Apr 4, 2022 - Abstract #EULAR2022EULAR_630;    
    Intriguingly, we observed a remarkable expansion of MPO-specific, IgM-expressing memory B cells in patients. This so far unrecognized, active IgM-compartment may be clinically relevant, as both mAb and plasma-derived polyclonal MPO-specific IgM strongly activated complement, a pathway thought to play a central role in AAV.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, Vifor, Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Kerendia (finerenone) / Bayer
    Journal:  New Drugs Update: Finerenone, Difelikefalin, and Avacopan. (Pubmed Central) -  Apr 2, 2022   
    Difelikefalin (Korsuva™) is FDA-indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). Avacopan (Tavneos™) is FDA-indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, Ultomiris IV (ravulizumab IV) / AstraZeneca
    Journal:  Application of C5 inhibitors in glomerular diseases in 2021. (Pubmed Central) -  Apr 1, 2022   
    New data in the domain of C5-inhibition in glomerular diseases are still limited and mainly focus on 1) the efficacy of ravulizumab, a long-acting C5 inhibitor in aHUS, and 2) the use of avacopan, a C5aR antagonist, in antineutrophil cytoplasmic antibody vasculitis. Several new studies ongoing or planned for the next few years will evaluate the efficacy of C5 inhibition in secondary thrombotic microangiopathy, C3 glomerulopathy, membranous nephropathy, or immunoglobulin A nephropathy.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
    C5a and C5aR is Prominently Associated with Tunnels in Severe Hidradenitis Suppurativa () -  Mar 21, 2022 - Abstract #AAD2022AAD_2534;    
    These findings suggest C5a/C5aR signaling, resulting in leukocyte activation and skin destruction, is a major driver of tunnel development and disease progression in severe HS. The data provide a potential mechanistic basis for the clinical improvement seen with avacopan treatment in patients with severe HS.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Nucala (mepolizumab) / GSK, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Review, Journal:  The management of anti-neutrophil cytoplasmic antibody-associated vasculitis: what has changed in the last 10 years? (Pubmed Central) -  Mar 11, 2022   
    For the induction of remission, rituximab is increasingly used in place of cyclophosphamide, particularly for patients with proteinase 3 (PR3)-associated vasculitis or relapsing disease, and those wishing to preserve their fertility...Avacopan, the complement C5a receptor inhibitor, is effective in the treatment of associated vasculitis and may replace glucocorticoids in the future...The anti-interleukin 5 monoclonal antibody, mepolizumab, is effective for the treatment of non-severe eosinophilic granulomatosis with polyangiitis. Several other targeted therapies are in the pipeline and further progress is expected in the coming years.
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
    Journal:  Avacopan for the treatment of ANCA-associated vasculitis. (Pubmed Central) -  Mar 3, 2022   
    The relevant pre-clinical, phase I, II and III findings with emphasis on the efficacy, and safety of avacopan, a new oral competitive inhibitor that interferes with the binding of C5a to C5aR1 (CD88), are reviewed. These results are encouraging, may led to major changes in the treatment approach for AAV, and give rise to future studies utilizing complement inhibitors in AAV patients, and potentially in other immune mediated diseases.
  • ||||||||||  Tavneos (avacopan) / Amgen
    Trial completion, Trial completion date:  Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA) (clinicaltrials.gov) -  Feb 25, 2022   
    P2,  N=398, Completed, 
    These results are encouraging, may led to major changes in the treatment approach for AAV, and give rise to future studies utilizing complement inhibitors in AAV patients, and potentially in other immune mediated diseases. Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Mar 2021
  • ||||||||||  Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
    Review, Journal:  Avacopan: First Approval. (Pubmed Central) -  Feb 19, 2022   
    Avacopan is being investigated for the treatment of complement component 3 glomerulopathy, hidradenitis suppurativa, lupus nephritis and IgA nephropathy. This article summarizes the milestones in the development of avacopan leading to these first approvals in Japan and the USA.