Health Canada7 Jul 2026
TAVNEOS (avacopan) and Health Canada’s Review of Data Integrity Concerns
Health Canada published a recall notice for TAVNEOS (avacopan) and Health Canada’s Review of Data Integrity Concerns on 7 Jul 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 7 Jul 2026
- Recall type
- Health professional risk communication
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: Health Canada is reviewing significant concerns regarding the data integrity of the pivotal ADVOCATE trial, which served as the primary efficacy study supporting the authorization of TAVNEOS (avacopan). AudienceHealthcare professionals involved in the treatment and management of patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, including rheumatologists, nephrologists, pulmonologists, internal medicine physicians, family physicians, nurse practitioners, and pharmacists. Key messagesHealth Canada has identified significant concerns about the data that supported the authorization of TAVNEOS (avacopan). These concerns raise questions about the efficacy of TAVNEOS. Pending the outcome of Health Canada’s review of these concerns, healthcare professionals are advised to:NOT initiate treatment with TAVNEOS in new patients.Contact and monitor patients currently receiving TAVNEOS and assess whether continued treatment remains appropriate. Background InformationTAVNEOS (avacopan) is indicated for the 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 background therapy including glucocorticoids. TAVNEOS is not indicated for use as monotherapy and does not eliminate glucocorticoid use.The authorization of TAVNEOS in Canada (April 2022) was supported primarily by the pivotal Phase 3 ADVOCATE trial, sponsored by ChemoCentryx, which evaluated the use of avacopan in patients with GPA or MPA receiving standard therapy.New information has raised significant concerns regarding the integrity of the clinical data from the ADVOCATE trial. The concerns relate to how the data for the ADVOCATE trial was handled before TAVNEOS was authorized, creating uncertainty about the reliability of the efficacy evidence supporting the product’s benefit-risk profile.Due to What to do: See key messages above Additional information Details Original published date: 2026-07-07 Affected products: TAVNEOS (avacopan) capsules, 10 mg Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.