Tavneos Lawsuit
Tavneos (avacopan) is an oral medication approved by the FDA in October 2021 as an add-on treatment for severe active ANCA-associated vasculitis, a group of rare autoimmune diseases that inflame small blood vessels. It was developed by ChemoCentryx, which Amgen acquired in 2022. In 2026, Tavneos became the subject of one of the most dramatic drug-safety stories in recent memory.
What Happened in 2026
On March 31, 2026, the FDA issued a Drug Safety Communication identifying 76 cases of drug-induced liver injury with reasonable evidence of a causal association with avacopan — 54 involving hospitalization and 8 involving death. Some cases involved vanishing bile duct syndrome (VBDS), a rare condition in which the bile ducts inside the liver are progressively destroyed, which can cause permanent liver damage. Then, on April 27, 2026, the FDA took the extraordinary step of proposing to withdraw Tavneos’s approval entirely, stating there is no substantial evidence the drug is effective and raising concerns that data in the pivotal clinical trial had been mishandled. That trial — ADVOCATE — was retracted by its publishing journal in June 2026, and European regulators have recommended revoking the drug’s authorization. Amgen has contested the withdrawal, and an FDA hearing is scheduled for July 2026. Tavneos remains on the U.S. market while the process plays out.
The Legal Claims Being Investigated
Attorneys are investigating claims on behalf of patients who suffered serious liver injury — drug-induced liver injury, vanishing bile duct syndrome, liver failure, hospitalization, liver transplant — or families who lost a loved one after Tavneos treatment. Potential claims focus on the adequacy of warnings, the handling of safety signals, and the integrity of the data used to bring the drug to market. This litigation is in its earliest investigative stage; no MDL has been formed and no settlements exist.
Who May Qualify?
You may qualify for a free case review if you or a family member took Tavneos for ANCA-associated vasculitis and were diagnosed with serious liver injury, vanishing bile duct syndrome, or liver failure, or required hospitalization or transplant — or if a loved one died after developing liver injury on the drug. Prescription records and liver-related medical records are the core evidence.
Important: If you currently take Tavneos, do not stop without talking to your doctor. Contact your healthcare professional immediately if you develop symptoms that may indicate liver injury, such as unusual fatigue, nausea, itching, yellowing of the skin or eyes, dark urine, or pain in the upper right abdomen.