The Food and Drug Administration has approved Tavneos™ (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including glucocorticoids.
ANCA-associated vasculitis is a systemic disease characterized by the inflammation and destruction of small blood vessels resulting in organ damage and failure. Tavneos is a first-in-class, orally-administered, small molecule designed to selectively block the complement 5a receptor (C5aR) on destructive inflammatory cells such as blood neutrophils.
The approval was based on data from the double-blind, active-controlled phase 3 ADVOCATE trial (ClinicalTrials.gov Identifier: NCT02994927), which evaluated the efficacy and safety of avacopan in 330 adults with newly diagnosed or relapsed ANCA-associated vasculitis. Patients were randomly assigned 1:1 to receive either avacopan 30mg twice daily or prednisone. All patients received either rituximab or cyclophosphamide, followed by azathioprine or mycophenolate. The co-primary endpoints were disease remission at week 26 and sustained disease remission at week 52.
Findings showed that 72.3% of avacopan-treated patients achieved disease remission (as assessed by Birmingham Vasculitis Activity Score) at week 26 compared with 70.1% of prednisone-treated patients, establishing noninferiority of the investigational treatment (P <.0001). At week 52, avacopan demonstrated statistical superiority in sustained remission compared with prednisone (65.7% vs 54.9%, respectively; P =.013).
The most common adverse reactions (incidence of 5% and higher in the avacopan group vs prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, increased blood creatinine, and paresthesia.
Tavneos is supplied as 10mg capsules in 30-count and 180-count bottles and is expected to be available in the next few weeks.
- ChemoCentryx announces FDA approval of Tavneos™ (avacopan) in ANCA-associated vasculitis. News release. ChemoCentryx, Inc. Accessed October 8, 2021. https://www.globenewswire.com/news-release/2021/10/08/2311086/19219/en/ChemoCentryx-Announces-FDA-Approval-of-TAVNEOS-avacopan-in-ANCA-Associated-Vasculitis.html.
- Tavneos. Package insert. ChemoCentryx, Inc,; 2021. Accessed October 8, 2021. https://www.chemocentryx.com/wp-content/uploads/2021/10/FINAL-PI-and-Med-Guide-7-Oct-21.pdf.