London, UK – The European Medicines Agency's human medicines committee has recommended revoking the marketing authorisation for Tavneos (avacopan) in the European Union, concluding that the medicine's benefits are no longer proven to outweigh its risks.
Tavneos is used to treat adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis, two rare inflammatory blood vessel conditions.
Data Integrity Concerns
The review was triggered by new information questioning the data integrity of the Advocate study, the pivotal trial supporting Tavneos' EU authorisation. The study compared a 52-week course of Tavneos plus a 20-week corticosteroid course against placebo plus corticosteroids, both combined with standard treatment.
After reviewing all available data, the CHMP concluded the Advocate study was conducted in breach of Good Clinical Practice principles. Study data provided during the initial assessment were found to be incorrect and misleading and can no longer be relied upon to demonstrate Tavneos' effectiveness. Supportive post-marketing data and post-hoc analyses were deemed insufficient.
Patient Safety Concerns
Tavneos is associated with an increased risk of drug-induced liver injury and vanishing bile duct syndrome, including fatal cases. Most cases occurred within the first three months of treatment.
The committee recommends that no new patients should start treatment with Tavneos. Current patients should be switched to suitable alternatives. For patients discontinuing treatment, close liver function monitoring is required:
Patients treated for less than three months: monitor every two weeks until three months from treatment start
Patients treated for more than three months: monitor every four weeks for up to six months, then as clinically needed
If vanishing bile duct syndrome is suspected, Tavneos must be immediately discontinued.
Next Steps
The CHMP opinion will be forwarded to the European Commission, which will issue a final legally binding decision applicable across all EU member states. If confirmed, Tavneos will no longer be authorised in the EU.
A direct healthcare professional communication will be sent to healthcare professionals prescribing, dispensing or administering the medicine.
