The FDA's Center for Drug Evaluation and Research (CDER) proposed withdrawing approval of Tavneos (avacopan) due to lack of substantial evidence of effectiveness and untrue statements in the application.23
New information revealed unblinded study personnel manipulated results of the pivotal ADVOCATE phase 3 study, making the drug appear effective when original analysis did not support it; this was not disclosed to FDA.23
Tavneos, approved October 7, 2021, treats severe active ANCA-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) alongside glucocorticoids and standard care.2
Additional safety concerns include serious drug-induced liver injury (DILI), some with vanishing bile duct syndrome (VBDS) and fatal outcomes, highlighted in a March 31, 2026, communication.2
Tavneos remains on the market pending the applicant's response or FDA Commissioner's decision; a notice of opportunity for a hearing was issued to ChemoCentryx, Amgen's subsidiary.23
FDA cited violations under sections 505(e)(3) and 505(e)(5) of the FD&C Act for lack of evidence and material untrue statements.3
Sources:
2. https://www.fda.gov/drugs/drug-alerts-and-statements/cder-proposes-withdraw-approval-tavneos