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- avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
[VIRTUAL] Drug Discovery & Development in ANCA-Associated Vasculitis (Virtual Room 4) - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_2290;
Faculty will focus on the relationship between biomarker discovery and randomized control trials with a particular emphasis on envisioning future clinical trials in AAV. Learning Objectives: Review whether candidate biomarkers in AAV predict treatment efficacy in related randomized controlled trials Discuss randomized controlled trial designs of the future in relationship to emerging candidate biomarkers and endotypes in AAV Summarize the findings from investigations of avacopan, an orally administered small-molecule C5a receptor antagonist, in AAV, and current data examining glucocorticoid-sparing approaches in AAV
- Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
[VIRTUAL] The Effect of Treatment with the Complement C5a Receptor Inhibitor Avacopan on Health-Related Quality of Life in ANCA-Associated Vasculitis (Room 7) - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_101;
These findings have important clinical implications for treatment of patients with AAV. 1.
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal, Adverse events: Strategies for effective treatment of ANCA-associated vasculitides with fewer side effects (Pubmed Central) - Sep 7, 2021
Rituximab and azathioprine are available options for maintenance of remission...New treatment approaches, such as the C5a receptor inhibitor avacopan could enable a minimized steroid treatment in the future...Supportive measures (e.g. vaccinations, infection prophylaxis, cardiovascular risk management) are increasing in importance. Future treatment strategies must take the individual risk (e.g. ANCA subtype, relapse risk) more into consideration for selection and duration of treatment.
- || avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Clinical, Journal: In ANCA-associated vasculitis, avacopan was superior to prednisone taper for sustained remission. (Pubmed Central) - Sep 2, 2021
2021;384:599-609. 33596356.
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical: Avacopan was noninferior to prednisone taper for inducing remission at 26 weeks and superior to prednisone taper with respect to sustained remission at 52 weeks in patients who received rituximab or cyclophosphamide. (Twitter) - Aug 2, 2021
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Journal: Avacopan in ANCA-associated vasculitis: the ADVOCATE trial (Pubmed Central) - Jul 28, 2021
33596356. No abstract available
- | Actemra IV (tocilizumab) / Roche, JW Pharma
Journal: Management of primary vasculitides with biologic and novel small molecule medications. (Pubmed Central) - Jul 24, 2021
Biologics and other novel therapies have an increasingly important role in the management of systemic vasculitis. Additional studies are needed to define their optimal use and to guide their use in more rare forms of vasculitis.
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Journal: Avacopan offers alternative to steroids for ANCA-associated vasculitis. (Pubmed Central) - Jul 17, 2021
Additional studies are needed to define their optimal use and to guide their use in more rare forms of vasculitis. No abstract available
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
$CCXI Thanks for the info - I expect SEEDHOUSE at RJ to chime in too, especially w the new developments at the FDA regarding CCX-168 (Twitter) - Jul 7, 2021
- |||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
NDA, PDUFA date, Review: $CCXI ChemoCentryx Announces Filing of Amendment to NDA Submission and Extension of the PDUFA Review Period for Avacopan in the Treatment of ANCA-Associated Vasculitis https://t.co/Pi0VQRfNde (Twitter) - Jul 6, 2021
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Benlysta (belimumab) / GSK, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: New therapeutic strategies in lung vasculitis: Current Opinion in Pulmonary Medicine, invited review. (Pubmed Central) - Jun 26, 2021
Significant advances have been made in the treatment strategy to both induce remission and maintain remission in patients with ANCA-associated vasculitis. The choice should take into consideration efficacy, cost-effectiveness, safety profile, ease of use, and possibility of individual tailoring of treatment.
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
I'd be very relaxed if y'all approved $CCXI's Avacopan 👀 (Twitter) - Jun 24, 2021
- || avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
FDA event: oh you know avacopan approval, roxadustat blessing, FDA just gonna burn it all down (Twitter) - Jun 15, 2021
- || avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, iptacopan (LNP023) / Novartis
#ERAEDTA21 2. gun toplantisi ise oldukca yeniliklerle doluydu. Gec klinik calisma sonuclarinda sunulan yenilikler heyecan vericiydi 📌Avacopan 📌Iptacopan📌SGLT2i GNlerde kullanimi gibi (Twitter) - Jun 6, 2021
- || avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
💥Avacopan in C3G : summary of the ACCOLADE RCT A.Bomback #ERAEDTA21 (Twitter) - Jun 6, 2021
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Journal: Avacopan for the Treatment of ANCA-Associated Vasculitis. (Pubmed Central) - Jun 3, 2021
The choice should take into consideration efficacy, cost-effectiveness, safety profile, ease of use, and possibility of individual tailoring of treatment. No abstract available
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Journal: Avacopan for the Treatment of ANCA-Associated Vasculitis. (Pubmed Central) - Jun 3, 2021
No abstract available No abstract available
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Journal: Avacopan for the Treatment of ANCA-Associated Vasculitis. Reply. (Pubmed Central) - Jun 3, 2021
No abstract available No abstract available
- avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
[VIRTUAL] ORALLY ADMINISTERED C5AR INHIBITOR AVACOPAN IN A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY (ACCOLADE) FOR TREATMENT OF C3 GLOMERULOPATHY (Hall A3-7 (Plenary)) - May 26, 2021 - Abstract #ERAEDTA2021ERA_EDTA_1790;
P2
No abstract available Data from the 26 week randomized blinded phase of ACCOLADE support that avacopan could benefit C3G.
- || Tavneos (avacopan) / Amgen
Enrollment closed, Trial completion date: ACCOLADE: Controlled Trial Evaluating Avacopan in C3 Glomerulopathy (clinicaltrials.gov) - May 17, 2021
P2, N=88, Active, not recruiting, Sponsor: ChemoCentryx
Data from the 26 week randomized blinded phase of ACCOLADE support that avacopan could benefit C3G. Recruiting --> Active, not recruiting | Trial completion date: May 2021 --> Oct 2021
- |||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Clinical: My Take: FDA PANEL MISSES THE MARK ON AVACOPAN - The prospects of Steroid reduced or steroid free regimen is incalculable to pts! @VasculitisFound @AdamJBrownMD FDA panel narrowly endorses avacopan for ANCA-associated vasculitis amid efficacy concerns https://t.co/8Lj9yGSNyz (Twitter) - May 15, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Clinical: Using avacopan holds the potential for a true steroid sparing regimen - early run in of pred noted but what options do we have to completely pull out steroids in ANCA and how often do we do it! I have no COI here and would want low/no steroids- many pts would agree (Twitter) - May 12, 2021
- |||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
News Feature: FDA Advisors Split on Avacopan for Vasculitis An FDA advisory panel was sharply divided as to whether avacopan, an oral small molecule inhibitor of the C5a receptor, was sufficiently safe/effective for treating ANCA-associated vasculitis. https://t.co/YqVEbqT5Oe (Twitter) - May 11, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Clinical: I believe the panel did not appreciate the impact of being able to Rx ANCA disease without STEROIDS!& so imp to pts !! @VasculitisFound @MdWarrington This is a sea change in #vasculitisFDA Advisors Split on Avacopan for Vasculitis | RheumNow https://t.co/NZVQUpZQvN (Twitter) - May 10, 2021
- ||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
FDA event: News Feature: Avacopan for ANCA Vasculitis Goes in Front of the FDA An FDA advisory panel will consider whether to recommend approval of an oral C5a inhibitor for ANCA-associated vasculitis. https://t.co/66NSjbkE8Q (Twitter) - May 9, 2021
- || Actemra IV (tocilizumab) / Roche, JW Pharma
Review, Journal: Cortisone-free rheumatology-Vasculitides (Pubmed Central) - May 7, 2021
Avacopan could in the future be an efficient agent to spare GC in the phase of remission induction in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), e.g. granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Mepolizumab is a promising option to reduce the use of GC in eosinophilic granulomatosis with polyangiitis (EGPA).
- avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
[VIRTUAL] Avacopan, a highly selective small molecule inhibitor of c5a receptor, in patients with Hidradenitis Suppurativa: Initial results from a randomized, double-blind, placebo-controlled, phase 2 study (aurora) () - May 4, 2021 - Abstract #SID2021SID_879;
P2
Avacopan also demonstrated a favorable safety profile in HS, with a lower incidence of treatment emergent adverse events (48.5% in avacopan groups vs. 55% with placebo), and serious adverse events (1.5% in the avacopan groups vs 2.3% in placebo). Avacopan’s use in a Hurley Stage III HS population warrants further investigation.
- || avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
So I am all for avacopan shows non inferior results at 26... but the superior at 52. That needs an asterisk #NephJC (Twitter) - Apr 21, 2021
- || avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Avacopan continued full 52 weeks and steroids stopped at 26... most studies give at least full year or more of steroids #NephJC (Twitter) - Apr 21, 2021
- || avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Way to pull the big guns into #nephjc! Avacopan-->Denver Nuggets scouting reports. (Twitter) - Apr 20, 2021
- |||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Clinical: What if a regimen of avacopan plus steroids was studied that allowed faster tapering and minimal use of steroids and maybe taper to off in some. Just like we do in kidney transplant pts. #nephjc (Twitter) - Apr 20, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Avacopan for the Treatment of ANCA-Associated Vasculitis ca. 2021 from @NEJM #NephJC #Nephpearls 👉🏼 https://t.co/8PDWy1i0oM 📺 https://t.co/W2aUndrH3V (Twitter) - Apr 20, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Avacopan for the Treatment of ANCA-Associated Vasculitis ca. 2021 from @NEJM #NephJC #Nephpearls 👉🏼 https://t.co/8PDWy1i0oM 📺 https://t.co/W2aUndrH3V (Twitter) - Apr 20, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Dallas Nephrologist here for #NephJC discussion on #Avacopan and AAV. No COI (Twitter) - Apr 20, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Avacopan: Steroid sparing drug during the induction phase of ANCA associated Vasculitis #Nephpearls #NephJC #VisualAbstract by @kidney_boy 👉🏼 https://t.co/vCTYVAfSMh (Twitter) - Apr 20, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Avacopan: Steroid sparing drug during the induction phase of ANCA associated Vasculitis #Nephpearls #NephJC #VisualAbstract by @kidney_boy 👉🏼 https://t.co/vCTYVAfSMh (Twitter) - Apr 20, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Anuja Java, transplant nephrologist @WUNephrology. Excited to be here tonight. No COI. Just tried saying Advocate, Avacopan & avocado! It’s a tongue twister😅. Why are there avocados on the pic though?? #nephjc (Twitter) - Apr 20, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Avacopan for the Treatment of ANCA Associated Vasculitis ca. 2021 from @NEJM #NephJC #Nephpearls #VisualAbstract by @Deep_Phachu 👉🏼 https://t.co/8PDWy1i0oM (Twitter) - Apr 20, 2021
- || Review, Journal: Vasculitis therapy refines vasculitis mechanistic classification. (Pubmed Central) - Apr 20, 2021
Taken together, clinical studies with cytokine and cell specific drugs are dissecting the heterogeneous immunopathogenic mechanisms of vasculitis and support a mechanistic immunological classification. Especially, cytokine antagonism is pointing towards immunological distinctions between eosinophilic granulomatosis with polyangiitis and granulomatosis with polyangiitis/microscopic polyangiitis and differences between giant cell arteritis and Takayasu arteritis.
- avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
[VIRTUAL] AVACOPAN IN ANCA-ASSOCIATED VASCULITIS: EVIDENCE FOR ELIMINATION OF DAILY PREDNISONE THERAPY AND REDUCTION IN GLUCOCORTICOID-RELATED TOXICITY FROM THE PHASE 3 ADVOCATE TRIAL () - Apr 17, 2021 - Abstract #ISNWCN2021ISN-WCN_947;
GC-induced toxicities were reduced with avacopan. These findings have important implications for the long-term health of ANCA-vasculitis patients through better overall disease control with reduced prednisone exposure and lessening of GC therapy-associated illnesses.
- ||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Clinical: David Jayne knocks down attacking complement with avacopan in ANCA disease- Game changing and tectonic for patients with vasculitis and beyond @VasculitisFound #vasculitis @AdamJBrownMD @alhkim @RareDiseases @RulaHajjAliMD @CCalabreseDO (Twitter) - Apr 8, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Wow. C5a receptor inhibitor avacopan won #RheumMadness. #Complement for the win! So what happened to complement in #NephMadness? (Twitter) - Apr 5, 2021
- avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
[VIRTUAL] THE EFFECT OF AVACOPAN, A COMPLEMENT C5A RECEPTOR INHIBITOR, ON KIDNEY FUNCTION IN PATIENTS WITH ANCA-ASSOCIATED VASCULITIS WITH RENAL DISEASE (Hall New York) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_423;
Avacopan also led to more rapid improvement in the UACR and urinary MCP-1:creatinine ratio than prednisone. Since albuminuria is an independent risk factor for progression of renal disease (in addition to eGFR decline), the more rapid improvement in albuminuriawith avacopan may also provide long-term benefit.
- | Soliris (eculizumab) / Alexion Pharma
Journal: Complement system and kidney (Pubmed Central) - Mar 3, 2021
As for kidney transplantation, complement modulators may lead to a new perspective in the treatment of some complications, such as humoral rejection. However, complement modulators carry the side effects, especially the infectious, and high costs.
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Reimbursement: Its a difference of 6 ml/ min. Not great but not bad either. The key is cost. If avacopan is non inferior at 26 weeks and superior at 52 weeks AND costs the same as prednisone, its a no brainer. But sadly we will be stuck with insurance companies (Twitter) - Feb 25, 2021
- || avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
avacopan group received some steroids too thats the reason they state it like that (Twitter) - Feb 25, 2021
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Avacopan for the Treatment of ANCA-Associated Vasculitis. (Pubmed Central) - Feb 24, 2021
P3
The safety and clinical effects of avacopan beyond 52 weeks were not addressed in the trial. (Funded by ChemoCentryx; ADVOCATE ClinicalTrials.gov number, NCT02994927.).
- | avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Journal: Avacopan - Time to Replace Glucocorticoids? (Pubmed Central) - Feb 24, 2021
(Funded by ChemoCentryx; ADVOCATE ClinicalTrials.gov number, NCT02994927.). No abstract available
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Will we be titrating the avacopan dose to degree of inflammation in the future? i.e. starting high and weaning down to minimum affective dose. Dose was 30mg BD all the way through in #ADVOCATE (Twitter) - Feb 21, 2021
- ||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Clinical: Bear in mind when looking at week 52 results that steroid wean protocol was to zero by 21 weeks, so second 6 months of follow up was avacopan v nothing. (Twitter) - Feb 21, 2021