Amgen Inc. (NASDAQ:AMGN) has formally requested a hearing to challenge the U.S. Food and Drug Administration‘s proposal to withdraw approval for Tavneos (avacopan).
The company argues that the drug's benefits continue to outweigh its risks for patients with a rare autoimmune disease.
The request, submitted by Amgen and its subsidiary ChemoCentryx, Inc., responds to a Notice of Opportunity for a Hearing issued by the FDA's Center for Drug Evaluation and Research (CDER) on April 30 regarding Tavneos.
Amgen Says Benefits Continue To Outweigh Risks
In its filing, Amgen said it plans to submit detailed data, analyses, and supporting information by June 29, 2026, to justify a formal hearing.
The company maintains that withdrawing Tavneos would not serve the interests of patients with antineutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis).
Amgen also argued that the FDA's proposed action raises "genuine and substantial issues of material fact" that warrant a hearing before any final decision is made.
The company said removing the drug from the market would not align with the statutory standards governing withdrawal proceedings and could negatively affect patients who rely on the therapy.
Company Highlights Rare Disease Patient Impact
Amgen emphasized that granting a hearing would give patients, caregivers and other stakeholders in the ANCA-associated vasculitis community an opportunity to participate in the process.
According to the company, such a hearing would encourage stakeholder engagement in regulatory decision-making.
In a June 1 letter posted in FDA records, Thousand Oaks, California-based Amgen disclosed that the Duke Clinical Research Institute began an independent review in February of data from the pivotal late-stage clinical trial that supported Tavneos' approval.
The institute is examining the study results that formed the basis for the drug's original approval, according to the letter.
Amgen cited the ongoing review in its response to the FDA's proposal regarding Tavneos.
AMGN Stock Price Activity: Amgen shares were down 0.05% at $357.32 at the time of publication Friday, according to Benzinga Pro data.
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