AMGN · 10-Q · 2026Q3 · Full report

Tavneos FDA Withdrawal Proposal

AMGEN INC · 2026-11-04 · Importance 47 · Surprise 60 · In source text

On April 27, 2026, FDA’s Center for Drug Evaluation and Research (CDER) proposed withdrawing TAVNEOS’s U.S. approval, citing alleged lack of substantial evidence of effectiveness and untrue material statements in the application; the proposal followed a March 2026 FDA communication about serious, including fatal, drug-induced liver injury cases. Amgen requested a hearing on June 1, 2026, and submitted supporting information on July 23, including real-world evidence and an independent blinded re-adjudication of study data; CDER had not responded to that submission as of the filing. The FDA may decide the proposal without granting a hearing, and any withdrawal would take effect on a date specified by the FDA Commissioner; the matter remains appealable to the U.S. Court of Appeals. The U.S. intangible asset had a $2.2 billion carrying value as of September 30, 2026, and changes to estimated cash flows could impair recoverability; TAVNEOS remains on the market during the process.

Key facts

• On April 27, 2026, CDER proposed withdrawing TAVNEOS approval, citing new information about substantial evidence of effectiveness and alleged untrue material statements in ChemoCentryx's application. source
• If withdrawal of TAVNEOS's U.S. marketing authorization is ultimately required, it would be subject to a date specified by the FDA Commissioner; future changes to estimated TAVNEOS cash flows could impair recovery of the related U.S. intangible asset. source
• Amgen's TAVNEOS U.S. developed-product-technology intangible asset had a carrying value of $2.2 billion as of September 30, 2026. source
• Amgen requested a hearing on the proposed TAVNEOS withdrawal on June 1, 2026, and submitted supporting information, including additional real-world evidence and an independent blinded re-adjudication, on July 23, 2026. source
• The FDA Commissioner’s decision on whether to withdraw TAVNEOS approval is pending; the related consolidated patent action was stayed on July 29, 2026, and administratively terminated without prejudice on August 4, 2026. source
• TAVNEOS will remain on the market while the FDA withdrawal process is pending. source

Impact estimates