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# Amgen Outlines Basis for Hearing in Tavneos Withdrawal Effort
- URL: https://www.fdaweb.com/amgen-outlines-basis-for-hearing-in-tavneos-withdrawal-effort/
- Published: 2026-06-12T12:00:00.000Z
- Updated: 2026-09-14T13:41:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161305

FDA is likely headed toward a rare public hearing that will contest its proposal to withdraw approval of Amgen's ANCA-associated vasculitis drug Tavneos ([see earlier story](https://www.fdaweb.com/tavneos-withdrawal-sought-over-data-manipulation-safety-risks/)), with the company arguing that the agency's case rests on disputed facts and that patients could lose an important treatment option if the decision stands.

In a[ just-posted 6/1 filing](https://downloads.regulations.gov/FDA-2026-N-1321-0056/attachment%5F1.pdf?ref=fdaweb.com), Amgen formally requested a hearing on the agency's April proposal to withdraw approval of Tavneos (avacopan), setting the stage for what could become one of the most closely watched drug withdrawal proceedings in recent years.

The company’s notice signaled that it intends to aggressively challenge the agency's position, arguing that "genuine and substantial issues of material fact" require a hearing before any final action is taken. Amgen cited a 2025 federal appeals court ruling involving Vanda Pharmaceuticals as support for its position.

The filing provides the clearest picture yet of Amgen's defense strategy. The company disclosed that an independent, blinded re-adjudication of the pivotal Phase 3 ADVOCATE trial was launched in February and is being conducted by the Duke Clinical Research Institute. The original ADVOCATE study formed the basis for Tavneos' approval.

In its filing, Amgen said it "continues to believe that the benefits of Tavneos outweigh its risks" and argued that removing the drug from the market would be "neither in the best interest of patients nor consistent with the statutory criteria."

Amgen also highlighted a lengthy list of ongoing and planned studies that it may use in its defense, including a Phase 4 post-marketing trial, comparative effectiveness analyses, real-world evidence studies, multiple international post-marketing surveillance programs, and several investigator-sponsored trials evaluating avacopan in vasculitis and related kidney diseases.

Notably, several of those efforts are focused on liver safety, an issue that has emerged as a central focus of the FDA's concerns. The company identified ongoing analyses of hepatic adverse events in Japan and the U.S., as well as studies examining potential genetic risk factors associated with hepatotoxicity.

Amgen framed the dispute as a rare-disease patient access issue, arguing that ANCA-associated vasculitis patients have limited treatment options and should have an opportunity to participate in the hearing process. The company pointed to FDA's recently launched rare disease initiatives, including the agency's Rare Disease Innovation Hub and Accelerating Rare Disease Cures program, as reasons the agency should grant a hearing.