The Vasculitis Foundation (VF) is aware of recent announcements regarding TAVNEOS (avacopan), a medication approved for the treatment of adults with severe active ANCA-associated vasculitis, including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). On January 16, 2026, the U.S. Food and Drug Administration requested a voluntary withdrawal of TAVNEOS from the U.S. market

At this time, TAVNEOS remains available in the United States. Amgen, the current manufacturer and distributor of this medication, has indicated that it is engaged in ongoing discussions with the US Food and Drug Administration following recent regulatory communications. No final determination has been issued by the FDA, and no changes to patient access have been announced. 

“For patients living with vasculitis, treatment decisions are deeply personal and often lifesaving,” said Joyce Kullman, Executive Director of the VF. “We know that uncertainty around a medication you rely on can be concerning. Patients should not make changes to their treatment without guidance from their healthcare provider, and we remain focused on ensuring the community has clear, accurate information as this situation continues to evolve.”

The VF does not provide medical advice. Patients and caregivers with questions about their individual care should consult their healthcare provider.

For the most current information, patients and clinicians are encouraged to review Amgen’s official updates:

• Patient information: www.amgen.com/tavneos-update
• Healthcare provider information: www.amgen.com/tavneos-prescribers

The VF will continue to monitor developments closely and share updates as appropriate.