Amgen Challenges FDA's Proposal to Withdraw Tavneos

Amgen is seeking an FDA hearing to challenge the proposed withdrawal of Tavneos, citing continued benefits of the drug. An independent review of pivotal clinical trial data by the Duke Clinical Research Institute is underway. The company will submit detailed data by June 29, 2026.

Amgen has requested an FDA hearing to dispute the proposed withdrawal of Tavneos, a medication used to treat ANCA-associated vasculitis . The company's argument for the hearing is based on the drug's continued benefits exceeding its risks. Detailed data to support this claim will be submitted by June 29, 2026.

In response to the FDA's proposal, the independent Duke Clinical Research Institute has initiated a thorough review of the pivotal clinical trial data . This review's findings will be part of the FDA hearing. Amgen is defending its drug as an essential treatment for patients reliant on Tavneos, implying that a withdrawal would have significant implications for their care.

The dispute carries weight for AMGN, which gained Tavneos through its acquisition of ChemoCentryx, and for the broader precedent of how the FDA weighs confirmatory evidence on accelerated-approval drugs. A withdrawal would remove a differentiated therapy from Amgen rare-disease franchise, while a favorable hearing outcome would protect that revenue stream. Investors will watch the June 29 data submission, the Duke review findings, and the FDA hearing timeline for resolution.