Health Canada Reviews TAVNEOS (Avacopan) Over Data Integrity Concerns in Key Trial

Health Canada has issued a health professional risk communication regarding TAVNEOS (avacopan) capsules, 10 mg, after identifying significant data integrity concerns tied to the pivotal ADVOCATE clinical trial that supported the drug’s original authorization in April 2022. The trial publication was formally retracted by the New England Journal of Medicine on June 29, 2026, prompting Health Canada to review whether TAVNEOS should remain authorized for use in Canada.

What Products Are Being Recalled?

The alert covers TAVNEOS (avacopan) capsules, 10 mg, which are indicated for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. This includes granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), used alongside standard background therapy such as glucocorticoids. TAVNEOS is not authorized for use as a standalone treatment and does not eliminate the need for glucocorticoids.

Why Was This Recall Issued?

TAVNEOS was authorized in Canada based largely on results from the pivotal Phase 3 ADVOCATE trial, sponsored by ChemoCentryx, which studied avacopan’s effectiveness in GPA and MPA patients receiving standard therapy. New information has since raised serious concerns about how the trial data was handled before the drug’s authorization, casting doubt on the reliability of the efficacy evidence used to support TAVNEOS’s benefit-risk profile. As a direct result of these data integrity issues, the ADVOCATE trial’s published findings were retracted by the New England Journal of Medicine. Health Canada is now formally reviewing this information to determine what impact it has on the drug’s continued authorization in the Canadian market.

Who Is Affected?

This communication is directed primarily at healthcare professionals involved in treating ANCA-associated vasculitis, including rheumatologists, nephrologists, pulmonologists, internal medicine physicians, family physicians, nurse practitioners, and pharmacists. Patients currently prescribed TAVNEOS, as well as those who may be considered for the therapy going forward, are also affected. Health Canada notes that the concerns raise questions specifically about how well TAVNEOS works, rather than introducing a new direct safety hazard, but the uncertainty is significant enough to change prescribing guidance nationwide.

What Should You Do?

Pending the outcome of Health Canada’s review, healthcare professionals are advised not to initiate treatment with TAVNEOS in any new patients. They should also proactively contact and monitor patients currently receiving the drug to reassess whether continued treatment remains appropriate given the uncertainty around its supporting evidence.

Patients currently taking TAVNEOS should not stop their medication on their own. Instead, they should contact their healthcare professional to discuss their treatment plan and whether an alternative therapy may be more suitable. Any serious or unexpected side effects experienced while taking TAVNEOS should be reported.

Reports can be sent to Otsuka Canada Pharmaceutical Inc. at 2250 Boul. Alfred Nobel, Suite 301, Saint-Laurent, Quebec, H4S 2C9, by toll-free phone at 1-877-341-9245, by fax at 1-844-268-9110, or by email at OCPI-AdverseEvents@otsuka-ca.com or OCPI-MedInfo@otsuka-ca.com. Adverse reactions can also be reported directly to Health Canada by calling 1-866-234-2345 toll-free or through the MedEffect Canada online reporting system. Further inquiries can be directed to the Pharmaceutical Drugs Directorate at 613-957-0368 or by email.

Official Statement

Health Canada stated that it ‘has identified significant concerns about the data that supported the authorization of TAVNEOS (avacopan)’ and that these concerns ‘raise questions about the efficacy of TAVNEOS.’ The agency confirmed it is communicating this safety information to healthcare professionals and Canadians through the Recalls and Safety Alerts Database, with further distribution through the MedEffect e-Notice email notification system. The notice was signed by Achim Obergfell, Senior Director of Medical Affairs, Cardiovascular and Renal, at Vifor Fresenius Medical Care Renal Pharma.