Last updated, June 2, 2026

We recognize the recent public discussion regarding TAVNEOS® (avacopan) and are sharing this message to provide healthcare professionals with important information based on the currently available evidence.

We remain committed to supporting the care of patients living with severe active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) - rare and serious forms of ANCA-associated vasculitis (AAV) associated with significant morbidity, mortality, and limited treatment options.

Based on the totality of evidence, including the references listed below, accrued from clinical trials and over nearly five years of use in the United States, Amgen remains confident in the overall benefit-risk profile of TAVNEOS. Evidence from the Phase 3 ADVOCATE trial, routine post-marketing safety surveillance, and real-world evidence in more than 8,000 treated patients in the U.S. has helped characterize the clinical profile of TAVNEOS and inform approaches to managing adverse events reflected in the label. This evidence base includes at least 23 published real-world studies globally involving more than 1200 reported patients1-9. Collectively, the evidence demonstrates the impact of TAVNEOS on supporting remission, reducing relapse risk, and improving kidney function and quality of life measures, all while reducing glucocorticoid exposure and associated toxicity. Additionally, ongoing prospective studies required by health authorities following the initial TAVNEOS approval, including AVACOSTAR in Europe (NCT05897684) and the global AVASET Phase 4 trial (NCT06072482), continue to systematically assess safety in TAVNEOS users.

At Amgen, patient safety is our top priority. TAVNEOS has a well-characterized and manageable safety profile. We take the risk of hepatic injury associated with TAVNEOS seriously. In 2024, following an evaluation of post-marketing safety reports, we proposed additional safety language to the FDA regarding the risk of vanishing bile duct syndrome for inclusion in the USPI. Accordingly, the guidelines for liver panel monitoring and discontinuation included in the USPI, which have been in place since the initial FDA approval, were updated May 29, 2026. A disproportionate number of serious hepatic events have been reported in Japan when compared with the US and Europe. The etiology of this difference is uncertain but could be due to genetic differences, use of concomitant treatments, or differences in monitoring. Ongoing studies may help improve our understanding of these differences.

Given the seriousness of AAV, its substantial burden, and the fact that TAVNEOS is the only FDA-approved, targeted oral treatment for severe active GPA and MPA, TAVNEOS remains an important treatment option for patients, where more targeted approaches that can be tailored to individual patients are needed.

Amgen remains committed to ongoing pharmacovigilance, transparent communication, and continued collaboration with the FDA, with the goal of supporting informed clinical decision-making for healthcare professionals and the patients they treat.

Please see below for a list of current real-world evidence supporting the TAVNEOS benefit-risk profile.

The FDA is accepting public comments regarding its proposal to withdraw approval of TAVNEOS. The public comment period is open through June 29, 2026 and you can provide comments here.


INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti- neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. In the postmarketing setting, vanishing bile duct syndrome (VBDS) as a consequence of liver injury, including cases with a fatal outcome, has been reported. These events occurred predominantly in Japan in patients aged 65 years and older, but VBDS may affect patients of any age or ethnicity who are receiving TAVNEOS. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. For patients of Japanese descent, consider more frequent laboratory testing: every 2 weeks after the start of therapy for the first 3 months, followed by laboratory testing every 4 weeks for the next 3 months of treatment, and as clinically indicated thereafter. If a patient receiving treatment with TAVNEOS presents with an elevation in alanine aminotransferase [ALT] or aspartate aminotransferase [AST] to >3 times the upper limit of normal, evaluate promptly and consider pausing treatment as clinically indicated. If AST or ALT is > 5 times the upper limit of normal (ULN), or ALT or AST > 3 times the ULN with total bilirubin > 2 times the ULN, or alkaline phosphatase ≥ 2 times the ULN, or if the patient has clinical symptoms such as jaundice or pruritus, discontinue TAVNEOS until TAVNEOS-induced liver injury is ruled out. Immediately and permanently discontinue TAVNEOS if VBDS is suspected. TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common.

ADVERSE REACTIONS

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

DRUG INTERACTIONS

Avoid co-administration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Consider dose reduction of CYP3A4 substrates when co-administering TAVNEOS. Co-administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. While taking TAVNEOS, limit simvastatin dosage to 10 mg daily (or 20 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Consult the concomitant CYP3A4 substrate product information when considering administration of such products together with TAVNEOS.

TAVNEOS is available as a 10 mg capsule.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.


References

  1. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021;384:599-609.
  2. Zonozi R, Aqeel F, Le D, et al. Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis. Kidney Int Rep. 2024;9(6):1783-1791.
  3. Zimmermann J, Sonnemann J, Jabs WJ, et al. Avacopan in Anti-Neutrophil Cytoplasmic Autoantibodies-Associated Vasculitis in a Real-World Setting. Kidney Int Rep. 2024;9(9):2803-2808.
  4. Gabilan C, Belliere J, Moranne O, et al. Avacopan for anti-neutrophil cytoplasm antibodies-associated vasculitis: a multicentre real-world study. Rheumatology (Oxford). 2025;64(4):2214-2219.
  5. Draibe J, Espigol‑Frigolé G, Cid MC, et al. The real-world use and effectiveness of avacopan in routine practice for the treatment of ANCA vasculitis. First experiences in Spain. Rheumatology (Oxford). 2025;64(4):2019-2026.
  6. Tagami G, Yamaguchi M, Sugiyama H, et al. Efficacy and safety of avacopan in antineutrophil cytoplasmic autoantibody-associated vasculitis: a retrospective cohort study in Japan. BMC Rheumatol. 2025;9(1):8.
  7. Chalkia A, Flossmann O, Jones R, et al. Avacopan for ANCA-associated vasculitis with hypoxic pulmonary haemorrhage. Nephrol Dial Transplant. 2024;39(9):1473-1482.
  8. van Leeuwen JR, Bredewold OW, van Dam LS, et al. Compassionate Use of Avacopan in Difficult-to-Treat Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Kidney Int Rep. 2022;7(3):624-628.
  9. Berke I, Keller F, Untersulzner C, et al. Systematic review of efficacy and safety of avacopan in real-world clinical practice. Kidney Int Rep. 2026;103753.