Amgen Fights FDA Proposal to Pull ANCA Vasculitis Drug TAVNEOS From the Market

Amgen submitted a new package of data to the FDA on July 23, 2026, defending TAVNEOS (avacopan) against a federal proposal to pull the drug from the US market, a dispute that directly affects patients currently relying on it for a rare and serious autoimmune disease.

TAVNEOS treats ANCA-associated vasculitis (AAV), a condition in which the immune system produces antibodies that attack small blood vessels, causing inflammation that can damage the kidneys, lungs, and other organs if untreated. The drug was originally approved in 2021 as an add-on treatment alongside standard therapy, including steroids, and Amgen acquired the company that developed it in 2022.

In April 2026, the FDA's Center for Drug Evaluation and Research proposed withdrawing TAVNEOS's approval, citing concerns about how the original developer had re-reviewed certain trial results for a subset of patients in the pivotal ADVOCATE trial, along with concerns about rare but serious liver injury linked to the drug, including a condition called vanishing bile duct syndrome. The FDA also raised concerns about statements made in the original marketing application.

Amgen has disputed the withdrawal proposal and requested a formal hearing. On July 23, the company submitted supporting materials that it says include more than 70 real-world studies covering over 2,200 patients, along with an independent re-examination by the Duke Clinical Research Institute that Amgen says confirmed the drug's noninferiority to standard steroid tapering for achieving remission at 26 weeks and sustained remission at 52 weeks.

Amgen has also acknowledged the liver safety concerns directly. The company updated TAVNEOS's prescribing information in May 2026 to strengthen warnings about hepatotoxicity, including vanishing bile duct syndrome, most cases of which have been reported in patients over 65 in Japan. The company maintains that, taken together with the drug's efficacy data, the benefit-risk profile still supports keeping TAVNEOS available.

For patients and physicians, this is an unusually consequential regulatory fight. ANCA-associated vasculitis is rare and can be life-threatening if not controlled, and treatment options remain limited, so a market withdrawal would remove one of the few targeted therapies available on top of standard immunosuppressive care. At the same time, the FDA's concerns about both the data re-adjudication and the liver injury signal are serious enough that the agency chose the unusual step of proposing withdrawal rather than simply updating the label.

The dispute is not resolved. A hearing process, if granted, would give Amgen the opportunity to formally contest the withdrawal before any final decision, and the company says it will continue working with the FDA in the meantime. Current TAVNEOS users have not been told to stop the medication, but patients with questions about ongoing treatment should talk to their prescribing physician about the latest safety guidance.