TAVNEOS was approved in October 2021 to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis.
What is ANCA?
ANCA-associated vasculitis is a group of rare diseases that cause dangerous inflammation in blood vessels. These autoimmune diseases most often cause damage to small and medium blood vessels when the autoantibodies mistakenly activate white blood cells to attack the body’s own healthy tissues. ANCA-associated vasculitis can affect your kidneys, lungs, heart, skin, nerves, and joints, among other body parts.
What is TAVNEOS (avacopan)?
TAVNEOS is a prescription medication approved to treat adults with severe ANCA-associated vasculitis. It is a C5aR1 agonist that is used for treatment in conjunction with other medicines, usually glucocorticoids.
TAVNEOS was developed by ChemoCentryx, Inc., a company acquired by pharmaceutical giant Amgen in 2022.
Why is the FDA Concerned?
More than three years after the new drug application for TAVENOS was approved, new information revealed that study personnel manipulated the results of clinical studies to make TAVNEOS appear more effective. The original data did not support that conclusion. The original analysis was not provided to the FDA, which is a direct violation of regulations. As a result, CDER can no longer conclude that TAVNEOS is effective or safe for its approved use.
What are the Safety Concerns?
On March 31, 2026, CDER identified cases of drug-induced liver injuries, sometimes referred to as “DILI,” and vanishing bile duct syndrome (VBDS) associated with TAVNEOS in an FDA Drug Safety Communication. VBDS results in progressive destructive and disappearance of bile ducts within the liver. These diseases can result in fatal outcomes and represent entirely new safety concerns. Across 92 reported cases of drug induced liver injuries, studies show 11 deaths, 7 life-threatening events, 45 hospitalizations, and a broader cluster of 14 reaction terms with 77 deaths. A trend in injuries like this is classified as accelerating.
What Happens Next?
CDER has proposed that TAVNEOS be withdrawn from the market and issued a Notice of Opportunity for a Hearing to ChemoCentryx, Inc., a wholly owned subsidiary of Amgen, Inc. This Notice provides the company with an opportunity to be heard regarding the concerns raised by CDER, before the FDA issues a final order on their decision of what to do (such as removing the drug from the market).
During this process, TAVNEOS will remain on the market. If ChemoCentryx, Inc. requests a hearing, the FDA commissioner will decide whether to hold a public hearing, and whether to withdraw FDA approval of the drug.
If you are a patient currently taking TAVNEOS, you should speak with your health care professional about your concerns. If you develop any symptoms that may indicate a liver injury, including: feeling more tired than normal; nausea; vomiting; itching; yellowing of skin or eyes; dark urine; swelling of the stomach or abdomen; or pain in the right upper abdomen, you should contact your doctor immediately.
If you or a loved one have experienced drug-induced liver injury or vanishing bile duct syndrome while using TAVNEOS, contact our attorneys by phone at (404)-523-7706 for a free consultation, or submit your case evaluation online.
