Last updated, July 24, 2026

At Amgen, patients are our highest priority. We are committed to keeping the AAV community informed about TAVNEOS through transparent and timely communication and will continue to share updates as new information becomes available. As always, patients should discuss any treatment decisions or questions with their healthcare provider.

TAVNEOS is and remains available as a treatment for ANCA-Associated Vasculitis (AAV) (Severe Active GPA or MPA).

TAVNEOS, which was originally developed and brought to market by ChemoCentryx, was approved by the FDA in October of 2021 and has been available and used by patients in the US for nearly five years. The FDA has proposed to withdraw TAVNEOS from the U.S. market. Amgen strongly disagrees with this proposal.

Amgen remains confident in TAVNEOS benefit-risk profile and that TAVNEOS has an important role in treating patients with severe, active ANCA-associated vasculitis.

  1. Is TAVNEOS still available? Will I still be able to get my next prescription or refill?

    Yes, TAVNEOS remains available in the U.S.: there is no change to TAVNEOS approval status, use or availability. Amgen is engaging with the FDA to determine a path forward, with patient safety, needs, and support as our top priorities. The process with the FDA could take months or longer to reach a final resolution.

    Patients currently receiving TAVNEOS should not make changes related to their treatment without first consulting the healthcare provider who prescribed the medicine. If you are currently taking TAVNEOS and have questions about getting your prescription, please talk with your pharmacy or your doctor who prescribed the medicine. Please contact Amgen Medical Information at 1-800-772-6436 (Monday - Friday, 8am-8pm EST) with any product-related questions.

  2. Is TAVNEOS safe to use?

    • As always, patient safety remains our priority. Amgen remains confident that TAVNEOS is an important and effective medicine for the treatment of severe active ANCA-associated vasculitis (GPA/MPA).
    • Hepatotoxicity (liver problems) is a known risk of TAVNEOS and was included in the approved label in 2021, with guidance for your doctor to conduct blood tests to check how well your liver is working.
    • Earlier this year, the FDA issued a Drug Safety Communication notifying patients and health care professionals about serious postmarketing cases including fatal cases of drug-induced liver injury associated with TAVNEOS. Based on ongoing pharmacovigilance, to date, there have been no known deaths in the U.S. linked to serious liver injury, including vanishing bile duct syndrome (VBDS), in the more than 8,000 patients in the U.S. treated with TAVNEOS.
    • In May 2026, the U.S. prescribing information for TAVNEOS was updated to include additional guidance for healthcare providers on monitoring liver health based on reports of rare but serious liver injury. The update reinforces the importance of routine blood tests before and during treatment to help identify potential liver problems early. It also provides guidance on when treatment should be paused or discontinued if certain liver test results become significantly abnormal or if signs or symptoms of liver injury develop while the cause is evaluated. The approved use of TAVNEOS for adults with severe active ANCA-associated vasculitis did not change, and patients should continue taking TAVNEOS as prescribed and speak with their healthcare provider if they have any questions.
    • Amgen continues to closely monitor safety information and work with health authorities to keep patients and healthcare providers informed. Patients should talk with their doctor about the benefits and risks of TAVNEOS and what it means for their individual care.
    • For any additional questions, please contact Amgen Medical Information at 1-800-772-6436 (Monday - Friday, 8am-8pm EST).

  3. What should patients know about reports of deaths due to serious liver injury in people treated with TAVNEOS?

    • Earlier this year, Japanese pharmaceutical company Kissei reported that out of over 8,500 patients who had been treated with TAVNEOS in Japan, there had been 20 fatal cases of serious liver injury. These figures include cases for which a causal relationship with the product could not be determined.
    • Health authorities in Japan have decided to update the Japanese prescribing information to include detailed information on liver test monitoring and treatment discontinuation rules and updated information on the cases of serious hepatic function disorder, including vanishing bile duct syndrome, that have been reported.
    • Since FDA approval in 2021, the U.S. prescribing information has included the risk of serious liver injury (hepatotoxicity) and has provided specific liver monitoring guidance for physicians and patients.
    • To date, there have been no known deaths in the U.S. linked to serious liver injury, including vanishing bile duct syndrome (VBDS), in the more than 8,000 patients in the U.S. treated with TAVNEOS.

  4. How has Amgen responded to the FDA?

    • In April 2026, the FDA issued a formal notice to Amgen requesting withdrawal, suggesting that TAVNEOS had not been shown to be effective, and that ChemoCentryx's original application to the FDA included untrue statements of material fact.
    • On July 23, 2026, Amgen submitted additional data and analyses to the U.S. Food and Drug Administration (FDA) in support of its request for a hearing regarding TAVNEOS. We believe it is important that the FDA fully consider the totality of the scientific evidence, the significant unmet needs of people living with AAV, and the voices of patients before making a final decision that could affect access to this important treatment option.

  5. What is the independent review (re-adjudication) of the TAVNEOS clinical trial and what did it find?

    An independent group of clinical experts from the Duke Clinical Research Institute conducted a review of key results from the TAVNEOS clinical trial (ADVOCATE) using the original patient data and pre-defined criteria. This review was performed to help address questions that had been raised about how remission outcomes were evaluated in the original clinical trial.

    Overall, the results from the independent review were generally similar to the results from the original clinical trial, reinforcing confidence that TAVNEOS can help patients reach and stay in remission.

    Amgen believes these findings, together with the growing body of clinical, real-world, and safety evidence, continue to support the favorable benefit-risk profile of TAVNEOS as an important treatment option for adults living with severe active AAV.

  6. Do the results of the independent review impact the availability of TAVNEOS?

    There is no change for patients in the U.S. at this time. TAVNEOS remains an FDA-approved treatment for adults with severe active AAV and remains available to patients in the U.S.

    Amgen has requested a hearing with the FDA so that all available scientific evidence, including this independent review, can be fully considered before a final decision is made. Amgen continues to stand behind TAVNEOS as an important treatment option and remains committed to working with the FDA to preserve access for patients. Patients currently receiving TAVNEOS should not make changes related to their treatment without first consulting the healthcare provider who prescribed the medicine.

  7. Who should I talk to if I have questions about my care?

    If you have questions about your treatment or next steps, talk with your doctor or healthcare team. They are the best source of advice for your individual situation. You can also contact Amgen Medical Information at 1-800-772-6436 (Monday - Friday, 8am-8pm EST) with any product-related questions. Information for Healthcare Providers is available here.

  8. What should I do if I’m in a current TAVNEOS clinical trial?

    There is no change to ongoing TAVNEOS clinical trials at this time. If you have a question about your current clinical trial, please reach out directly to the clinical trial site coordinator.


IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TAVNEOS?

TAVNEOS may cause serious side effects, including:

  • Liver problems. People taking TAVNEOS may have serious liver problems, including a type of liver injury called vanishing bile duct syndrome (VBDS) that causes the loss of bile ducts in the liver. VBDS is severe and can lead to death. VBDS has been reported predominantly in Japan in patients aged 65 years and older but can happen to anyone. Call your healthcare provider right away if you have unexplained symptoms such as:
    • yellowing of your skin or the white part of your eyes (jaundice)
    • itchy skin (pruritus)
    • pain on the upper right side of your stomach area (abdomen)
    • feeling tired
    • dark or brown (tea colored) urine
    • bleeding or bruising more easily than normal
    • loss of appetite

Your healthcare provider will do blood tests to check how well your liver is working before starting and during your treatment with TAVNEOS. If you are of Japanese descent, your healthcare provider may recommend additional liver function testing and monitoring.

Do not take TAVNEOS if you are allergic to avacopan or any of the other ingredients in TAVNEOS.

  • Get medical help right away if you experience swollen lips, tongue, throat, trouble swallowing, or difficulty breathing. These could be signs of an allergic reaction. Do not take more of TAVNEOS until you have consulted with your healthcare provider.

Before taking TAVNEOS, tell your healthcare provider about all your medical conditions, including if you:

  • have or have had abnormal liver blood tests.
  • have or have had liver problems.
  • have or think you may have hepatitis B or hepatitis C.
  • have an infection.
  • are pregnant, planning to become pregnant, or breastfeeding.

Tell your healthcare provider about all the other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAVNEOS and certain other medicines may affect each other and cause side effects. Keep a list of the medicines you take and show it to your healthcare provider and pharmacist.

  • Some medicines should not be taken with TAVNEOS.
  • Your healthcare provider may prescribe other medicines to treat your disease.

TAVNEOS may cause serious side effects, including:

  • Liver problems (see above).
  • Serious allergic reactions. Stop taking TAVNEOS and get emergency medical help right away if you have any of the following signs of a serious allergic reaction: shortness of breath or trouble breathing; swollen lips, tongue, throat, or face; trouble swallowing; chest pain; feeling dizzy or faint; moderate or severe abdominal pain, or vomiting.
  • Hepatitis B virus (HBV) reactivation. If you have had HBV or are a carrier of HBV, taking TAVNEOS could cause the virus to become an active infection again. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or the white part of your eyes during treatment with TAVNEOS.
  • Serious infections. Serious infections can happen in people taking TAVNEOS, and these infections can lead to death. The most common serious infections with TAVNEOS were pneumonia and urinary tract infections. People with serious infections should not take TAVNEOS. Tell your healthcare provider right away if you have any symptoms of infection: fever, cold symptoms that do not go away, flu symptoms, pain during urination, or other signs of infection.

The most common side effects of TAVNEOS include:

  • nausea, headache, high blood pressure, diarrhea, vomiting, rash, tiredness, stomach pain, dizziness, increase in blood creatinine, and burning or prickling sensation.

These are not all the possible side effects of TAVNEOS. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is TAVNEOS?

TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)- associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener’s granulomatosis, and microscopic polyangiitis [MPA]).

It is not known if TAVNEOS is safe and effective in children under the age of 18.

TAVNEOS is available as a 10 mg capsule.

Please see the full Prescribing Information and Medication Guide.