Where things stand with TAVNEOS: Amgen makes its case to the FDA

ERDC Community Update

A woman in our community once told us that TAVNEOS was the first thing in years that let her feel like herself again — off the high-dose steroids that had reshaped her body and her mood, and back to a version of her disease she could live with. Stories like hers are why ERDC has stayed so closely engaged in the fight over whether this medication stays on the market.

On July 23, 2026, Amgen filed a 104-page submission with the FDA formally requesting a hearing on the agency’s proposal to withdraw TAVNEOS (avacopan). We want our community to understand what’s in that filing, what it means, and where we stand.

Our position hasn’t changed

ERDC continues to follow this closely, and our view remains consistent: TAVNEOS should remain available as a treatment option for people with ANCA vasculitis. Real-world evidence has shown, over and over, that it works for people living with this disease — reducing relapse, easing kidney damage, and most importantly, cutting down the amount of prednisone people need to carry in their bodies long-term.

That doesn’t mean TAVNEOS is risk-free. No medication is. Like every drug our community relies on, it comes with a serious list of possible side effects, and it needs to be monitored closely by a doctor — regular liver labs, watching for warning signs, adjusting course when needed. Prednisone is no exception either. The steroid that AAV treatment has depended on for decades carries its own long list of risks: bone loss, diabetes, weight gain, infection, mood changes, and more. Weighing a treatment’s risks against the realistic alternative — not against an imaginary risk-free option — is exactly the kind of decision people with rare disease and their doctors make every day, and it’s exactly why we believe the choice to use TAVNEOS should stay on the table.

What Amgen’s FDA submission says

Amgen’s filing pushes back hard on the FDA’s April 30 proposal to withdraw TAVNEOS, which rested on two grounds: that new information undercuts the substantial evidence of effectiveness behind the original approval, and that the application contained untrue statements of material fact. The FDA’s Center for Drug Evaluation and Research (CDER) has said that unblinded personnel at ChemoCentryx, the drug’s original sponsor, manipulated endpoint results in the pivotal ADVOCATE trial back in 2019.

Amgen disputes that characterization. The company says the 2019 review was a prespecified readjudication (reanalysis) procedure that reclassified how endpoints were scored for nine patients under rules set before the trial began, and that no underlying clinical data were changed. Amgen does acknowledge it should have disclosed the readjudication in its original application, and says it did not learn the full details until years later, during unrelated securities litigation.

Central to Amgen’s case is a new, independent, blinded readjudication of the ADVOCATE data conducted this year by the Duke Clinical Research Institute. That reanalysis found TAVNEOS noninferior to a prednisone taper for remission at week 26 and for sustained remission at week 52, with a numerical difference favoring TAVNEOS at week 52, even though statistical superiority wasn’t reached at either point. Notably, people on TAVNEOS in that reanalysis needed roughly 80% less steroid exposure than those on the prednisone taper.

Amgen is asking the FDA to rescind the withdrawal proposal outright. Short of that, the company wants a legal ruling in its favor or, at minimum, a hearing — including a citizen petition requesting review by a public advisory committee, given the scale of public interest from the rare disease community.

On the liver safety questions

Amgen’s submission is careful to note that safety was not the basis for the FDA’s withdrawal proposal — this is a dispute about trial conduct and effectiveness data, not about the vanishing bile duct syndrome (VBDS) warning our community has heard about. On that front, Amgen reports that the serious liver events, including VBDS, are heavily concentrated in Japan, with 27 of 31 total reported cases there, and none reported in the US. The company submitted updated liver safety labeling that took effect in May 2026.

The bottom line for our community

This remains, at its core, a regulatory dispute over how a nine-patient data review was handled seven years ago — not a finding that TAVNEOS doesn’t work or isn’t safe when monitored properly. Nearly five years after approval, no other therapy has been approved for AAV, and the alternatives — prolonged steroid courses, rituximab, cyclophosphamide — carry their own serious, well-documented risks.

ERDC will keep watching this process, and we’ll keep speaking up for the people in our community who have told us, again and again, what this medication has meant for their lives. We hear you. We see you. Because we are you.

Source: Sue Sutter, “New ADVOCATE Analysis Backs Tavneos Efficacy, Amgen Tells US FDA In Withdrawal Dispute,” Pink Sheet, July 24, 2026; and Amgen’s statement on its FDA data submission for TAVNEOS, July 23, 2026.