Official Statement
Important Information for the Vasculitis Community Regarding TAVNEOS® (avacopan)
April 30, 2026
The Vasculitis Foundation is aware of recent updates from the U.S. Food and Drug Administration regarding Tavneos (avacopan), including safety communications and ongoing regulatory discussions with Amgen.
At this time, the information available reflects what has been publicly released by the FDA and Amgen. These updates include reports of serious liver injury associated with Tavneos, as well as continued evaluation of the medication by the FDA. We are closely monitoring this evolving situation and will share updates as more information becomes available.
“We recognize that updates like this can be concerning for patients and families,” said Joyce Kullman, Executive Director of the Vasculitis Foundation. “Our priority is to ensure the community has access to accurate, timely information while encouraging patients to make informed decisions in partnership with their healthcare team.”
The Vasculitis Foundation does not endorse any specific medications and does not provide medical advice. Treatment decisions are highly individualized, and patients should not discontinue or change their treatment without first consulting their healthcare provider.
For the most current information, patients and clinicians are encouraged to review official updates from the FDA and Amgen:
April 30, 2026
Last Updated May 15, 2026
Last Updated May 22, 2026
Last Updated June 2, 2026
Living with ANCA-associated vasculitis (AAV)?
The National Kidney Foundation (NKF) and Vasculitis Foundation (VF) are working together to learn more about patients’ thoughts and experiences related to the FDA review of Tavneos (avacopan), a medicine approved in 2021 to treat ANCA-associated vasculitis (in combination with steroids).
This survey will ask about your awareness, opinions, and experiences related to this FDA proposal. You can expect the survey to take about 15 minutes to complete.
Do you treat patients with ANCA-associated vasculitis (AAV)?
The National Kidney Foundation (NKF) and Vasculitis Foundation (VF) are partnering to better understand clinicians’ perspectives regarding the regulatory review of Tavneos (avacopan), a treatment option approved in October 2021 for ANCA-associated vasculitis (in combination with glucocorticoids).
This survey is intended to assess clinicians' awareness, sentiment, and patient care implications regarding CDER’s proposal. You can expect the survey to take about 15 minutes to complete.
MEDICAL EDUCATION WEBINAR
Avacopan (Tavneos®) in GPA and MPA 2026:
FDA Updates, Safety Information, and What Patients Need to Know in 2026
Avacopan (Tavneos®) has become an important treatment option for some people living with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Recent statements from the U.S. Food and Drug Administration (FDA) have raised new questions about the medication’s safety, effectiveness, and future availability.
In this special Vasculitis Foundation webinar, Dr. Alexandra Villa-Forte of Cleveland Clinic and Dr. Kevin Byram of Vanderbilt University Medical Center provide clear, patient-centered information about what these developments mean for people living with GPA and MPA vasculitis.
This webinar covers:
• What Tavneos is and how it works
• How Tavneos is used in GPA and MPA treatment
• The FDA’s recent statements and regulatory updates
• What Amgen is doing in response
• Questions patients may want to discuss with their healthcare team
• How patients can submit comments to the FDA about their experience with Tavneos
Designed for patients and caregivers, this session aims to help the vasculitis community better understand the current situation and feel more informed when discussing treatment decisions with their medical providers.
During the webinar, Dr. Villa-Forte and Dr. Byram address many of the most common questions patients have raised about Tavneos and the evolving regulatory landscape. This webinar will address pre-submitted questions from the community.
The views and information shared during this webinar are intended for educational purposes only and do not represent official statements from the FDA or Amgen. The Vasculitis Foundation and webinar speakers are independent of both organizations. Patients should discuss treatment decisions with their healthcare team.
Share Your Experience with the FDA
The U.S. Food and Drug Administration (FDA) is accepting public comments regarding its proposal to withdraw approval of Tavneos (avacopan).
Patients, caregivers, and healthcare professionals are invited to share their experiences. Comments may be submitted anonymously if preferred.
The public comment period is open through June 29, 2026.
What You Can Share
Your perspective can help inform the FDA’s review. You may choose to share:
- Your experience living with vasculitis
How does GPA, MPA, or another form of vasculitis affect your daily life? - Your experience with glucocorticoids (steroids)
What side effects have you experienced? How have steroids impacted your quality of life? - Your experience with Tavneos (avacopan)
If you have taken or are currently taking Tavneos, what has your experience been? Has it helped manage your disease? Have you experienced side effects? - Caregiver perspectives
If you care for someone with vasculitis, you may share how the disease and its treatments have affected your loved one and your family.
Submit Your Comment
Online (Recommended)
Submit your comment directly through the FDA website:
Agency Docket No. FDA-2026-N-1321
By Mail or Delivery
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Include: Agency Docket No. FDA-2026-N-1321
Previous Updates
March 31, 2026
Updated Drug Safety Communication
On Tuesday, March 31, 2026, the FDA released a drug safety communication regarding Tavneos.
FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis
What is the FDA doing?
FDA is alerting patients and health care professionals about serious postmarketing cases, including fatal cases, of drug-induced liver injury (DILI) associated with Tavneos (avacopan). Some cases involved vanishing bile duct syndrome (VBDS), which is characterized by progressive destruction and disappearance of the bile ducts in the liver. This condition can slow or stop the flow of bile and may lead to permanent liver damage. VBDS is often accompanied by the yellowing of skin or eyes (jaundice), itchiness, and tiredness.
Although hepatotoxicity is a serious adverse reaction for Tavneos identified in premarket clinical trials and described in product labeling, VBDS and DILI cases with fatal outcomes represent new safety concerns. FDA is continuing to monitor postmarketing cases of DILI, including VBDS, involving Tavneos and will provide updates as appropriate.
To read the complete drug safety communication, please click here. The communication includes guidance for patients and health care professionals to follow as well as information on what the FDA learned from their review of the data.
To download a PDF of the communication, please click here.
For the most current information, patients and clinicians are encouraged to review Amgen’s official updates:
- Patient information: www.amgen.com/tavneos-update (Updated April 1, 2026)
- Healthcare provider information: www.amgen.com/tavneos-prescribers (Updated April 1, 2026)
The VF will continue to monitor developments closely and share updates as appropriate.
February 4, 2026
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.
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