Granulomatosis with Polyangiitis
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Sign up freeTop drugs studied for this disease
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EMA approval · 2025-08-05EMA Authorised: Riximyo (rituximab) — Sandoz GmbH
EMA authorized the biosimilar Riximyo (rituximab) by Sandoz GmbH for multiple indications, including Non-Hodgkin lymphoma, rheumatoid arthri…
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EMA approval · 2025-01-31EMA Authorised: Tavneos (avacopan) — Vifor Fresenius Medical Care Renal Pharma France
The European Medicines Agency authorised Tavneos (avacopan) for microscopic polyangiitis and granulomatosis with polyangiitis (Wegener's gra…
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CLINICAL_TRIALS research · 2025-01-17Clinical Trial Update: Special Drug Use-results Survey for Long-term Use（Avacopan）
A long-term-use results survey for avacopan in microscopic polyangiitis and granulomatosis with polyangiitis is currently recruiting in a st…
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CLINICAL_TRIALS research · 2024-09-03Clinical Trial Update: Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases. [Phase 1]
Open-label Phase 1 study evaluating the safety and preliminary efficacy of combining Rituximab with AB-101 in B-cell–associated autoimmune d…
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CLINICAL_TRIALS trial_result · 2024-08-27Clinical Trial Update: Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA) [Phase 3]
Phase 3 trial evaluating mycophenolate mofetil for relapses of granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic p…
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CLINICAL_TRIALS trial_result · 2024-07-31Clinical Trial Update: PR3-AAV Resilient Remission or PRRR [Phase 2]
A Phase 2 trial of PR3-AAV Resilient Remission (PRRR) for ANCA-associated vasculitis, including granulomatosis with polyangiitis and microsc…
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CLINICAL_TRIALS trial_result · 2024-07-29Clinical Trial Update: Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) [Phase 3]
This document reports the completion of a Phase 3 trial evaluating abatacept for relapsing, non-severe granulomatosis with polyangiitis (Weg…
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CLINICAL_TRIALS trial_result · 2024-07-29Clinical Trial Update: The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach [Phase 3]
The Phase 3 TAPIR trial evaluates prednisone in remission for granulomatosis with polyangiitis. The trial is currently active but not recrui…
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CLINICAL_TRIALS trial_result · 2024-07-19Clinical Trial Update: Hydroxychloroquine in ANCA Vasculitis Evaluation [Phase 4]
Phase 4 trial update evaluating hydroxychloroquine for ANCA-associated vasculitis, including microscopic polyangiitis, eosinophilic granulom…
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FDA approval · 2024-06-03FDA Approved: TAVNEOS — Supplemental Application (ChemoCentryx, Inc.)
The FDA approved a supplemental application for TAVNEOS (avacopan) submitted by ChemoCentryx, expanding its regulatory status for the treatm…
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CLINICAL_TRIALS trial_result · 2022-09-09Clinical Trial Update: A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis [Phase 3]
Phase 3 trial of avacopan (CCX168) in ANCA-associated vasculitis has completed, with results posted.
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CLINICAL_TRIALS trial_result · 2022-08-25Clinical Trial Update: Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. [Phase 2]
Phase 2 clinical trial updating the use of IFX-1 as an alternative to steroids in Granulomatosis with Polyangiitis and Microscopic Polyangii…
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CLINICAL_TRIALS trial_result · 2022-07-06Clinical Trial Update: A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis [Phase 4]
Phase 4 trial evaluating safety and efficacy of rituximab combined with glucocorticoids in Wegener's Granulomatosis (granulomatosis with pol…
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FDA approval · 2022-06-03FDA Approved: RIABNI — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for RIABNI (rituximab-arrx) from Amgen. The action updates RIABNI’s labeling to reflect its approved…
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CLINICAL_TRIALS trial_result · 2022-05-26Clinical Trial Update: Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA [Phase 2]
Phase 2 safety and efficacy study of IFX-1 add-on to standard of care in GPA and MPA was terminated with results posted.
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CLINICAL_TRIALS trial_result · 2022-03-08Clinical Trial Update: Rituximab and Belimumab Combination Therapy in PR3 Vasculitis [Phase 2]
A Phase 2 trial evaluating Rituximab and Belimumab combination therapy for ANCA-associated vasculitis, including granulomatosis with polyang…
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FDA approval · 2021-12-02FDA Approved: RITUXAN — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Rituxan (rituximab) filed by Genentech, Inc., resulting in updated labeling for the product.
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FDA approval · 2021-10-07FDA Approved: TAVNEOS — Original Application (ChemoCentryx, Inc.)
FDA approved Tavneos (avacopan) from ChemoCentryx for adults with ANCA-associated vasculitis, in combination with standard therapy, includin…
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CLINICAL_TRIALS trial_result · 2021-07-09Clinical Trial Update: Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA [Phase 4]
Phase 4 trial comparing tofacitinib vs methotrexate for maintained treatment of granulomatosis with polyangiitis.
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FDA approval · 2020-12-17FDA Approved: RIABNI — Original Application (Amgen, Inc)
FDA approved RIABNI (rituximab-arrx) from Amgen as a biosimilar to rituximab via Original Application.
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CLINICAL_TRIALS trial_result · 2020-05-26Clinical Trial Update: Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis [Phase 3]
Phase 3 trial updating the use of plasma exchange and glucocorticoids for ANCA-associated vasculitis, with completion and results posted.
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FDA approval · 2019-07-23FDA Approved: RUXIENCE — Original Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved Ruxience (rituximab-pvvr) from Pfizer as a biosimilar to rituximab, under an original application; the approval covers multiple…
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CLINICAL_TRIALS trial_result · 2019-06-26Clinical Trial Update: A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis [Phase 2]
Phase IIa study evaluating intravenous rituximab in pediatric participants with granulomatosis with polyangiitis or microscopic polyangiitis…
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FDA approval · 2019-05-23FDA Approved: TRUXIMA — Supplemental Application (Cephalon, Inc.)
FDA approved a supplemental application for TRUXIMA (rituximab-ABBS) submitted by Cephalon, Inc.
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FDA approval · 2019-04-23FDA Approved: AZATHIOPRINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for azathioprine from Zydus Lifesciences Limited.