The UK Immuno-Vasculitis Society (UKIVAS) has published a statement regarding recent regulatory developments relating to Tavneos® (avacopan), including actions and reviews by the FDA and EMA.
The statement outlines:
- the FDA proposal to withdraw approval of Tavneos in the USA
- the ongoing EMA review relating to concerns around data integrity in the ADVOCATE study
- updated safety information relating to serious drug-induced liver injury (DILI)
At present, no formal statement has been issued by the MHRA.
Read the full UKIVAS statement here
Additional clinical note from the UKKA GN SIG
Representatives from our Glomerulonephritis Special Interest Group ask clinicians to remain aware of reported cases of drug-induced liver injury (DILI), including vanishing bile duct syndrome (VBDS), associated with avacopan:
There are two aspects to this issue, one is the efficacy, and the other is the liver toxicity. Foremost, our priority is to our patients. DILI has been seen more often in Asian patients, particularly in Japan, with eight Japanese patients of low body weight who were also taking co-trimoxazole reported to have developed VBDS so far. We need to explain to our patients both issues and take this into consideration when discussing new patients in the MDT and monitor liver function. We will update once the MHRA has given us guidance and in case of further developments across the globe.”
Clinicians are advised to continue discussing treatment options with patients through routine MDT and clinical decision-making processes, while ensuring appropriate liver function monitoring for patients receiving avacopan.
Patient information is also available from: