Amgen's Tavneos Faces Retraction and EMA Revocation Ahead of Critical FDA Hearing Deadline

Amgen's Tavneos Faces Retraction and EMA Revocation Ahead of Critical FDA Hearing Deadline

Amgen's autoimmune drug Tavneos (avacopan) is facing severe global regulatory headwinds ahead of a crucial July 29, 2026 deadline to save the drug from market withdrawal in the United States.

NEJM Retraction and EMA Revocation Recommendation

The scientific foundation of the drug was severely compromised on June 29, 2026, when the New England Journal of Medicine (NEJM) formally retracted the pivotal paper on the Phase 3 ADVOCATE trial¹, which had supported Tavneos's original FDA approval in 2021. The journal concluded that endpoint assessments for nine patients were improperly re-adjudicated after database lock, a practice deemed "inconsistent with proper research conduct." This finding aligned directly with the FDA's long-standing concerns regarding data integrity.

Adding to the pressure, on June 26, 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended revoking the drug's marketing authorization in the European Union, citing the "incorrect and misleading data" from the ADVOCATE trial.

High-Stakes FDA Hearing Deadline

Amgen, which acquired Tavneos through its $3.7 billion takeover of ChemoCentryx in 2022, has steadfastly refused the FDA's voluntary withdrawal requests. The company requested a formal hearing, and the deadline to submit its comprehensive defense—including an independent re-adjudication of the ADVOCATE trial data by the Duke Clinical Research Institute (DCRI)—was extended to July 29, 2026.

Tavneos represents a small but rapidly growing asset for Amgen. The drug generated $459 million in sales in 2025 (approximately 1% of Amgen's total revenue) and grew by 62% year-over-year. More importantly, Amgen carries $2.4 billion in developed-product intangible assets related to the drug on its balance sheet, meaning a full market withdrawal would trigger a massive write-down and impact rare-disease franchise projections.