Amgen Challenges FDA to Keep $500M ANCA Drug Tavneos on Market
AMGN•Amgen has formally requested an FDA hearing to challenge the proposed withdrawal of its ANCA-associated vasculitis treatment Tavneos and will submit Duke Clinical Research Institute’s independent trial data analysis by June 29. Tavneos, acquired for $3.7 billion, generates about $500 million in annual sales and faces safety and data integrity concerns.
1. Amgen Requests FDA Hearing
Amgen has filed a formal request for an FDA hearing to contest the agency’s proposed withdrawal of Tavneos, its ANCA-associated vasculitis treatment, and plans to submit a comprehensive data package, including Duke Clinical Research Institute’s independent analysis, by June 29.
2. Independent Review by Duke Clinical Research Institute
Duke began reviewing the pivotal trial data in February to provide an independent assessment of Tavneos’ efficacy and safety, adding a fresh layer of scrutiny as Amgen prepares its defense against the FDA’s withdrawal proposal.
3. Financial Impact and Acquisition
Tavneos generates roughly $500 million in annual sales and was acquired through Amgen’s $3.7 billion purchase of ChemoCentryx in 2022, making its continued market approval critical to recouping the acquisition investment and sustaining revenue growth.
4. Regulatory Concerns and Next Steps
FDA concerns include potential manipulation of trial data and reported safety issues, such as eight deaths in clinical use and additional fatalities overseas. Amgen will review Duke’s findings and engage with regulators ahead of the June 29 submission to secure Tavneos’ market status.
