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Tavneos FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 11, 2021.

FDA Approved: Yes (First approved October 7, 2021)
Brand name: Tavneos
Generic name: avacopan
Dosage form: Capsules
Company: ChemoCentryx, Inc.
Treatment for: ANCA-Associated Vasculitis

Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist for the adjunctive treatment of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.

  • ANCA-associated vasculitis is a group of diseases that includes granulomatosis with polyangiitis and microscopic polyangiitis. It is caused by complement-induced neutrophil activation. Neutrophils attack the small blood vessels in organs such as the kidneys, stomach, intestines, and lungs leading to organ damage and failure.
  • Tavneos is the first FDA-approved orally-administered inhibitor of the complement 5a receptor (C5aR). It works by blocking the C5aR to inhibit C5a-mediated neutrophil activation.
  • Tavneos capsules are taken twice daily, with food.
  • Tavneos may cause serious adverse reactions, including hepatotoxicity, serious hypersensitivity reactions, hepatitis B virus (HBV) reactivation, and serious infections.
  • Common side effects include nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, increased blood creatinine levels, and paresthesia.

Development timeline for Tavneos

Oct  8, 2021Approval FDA Approves Tavneos (avacopan) for the Adjunctive Treatment of ANCA-Associated Vasculitis
Jul  6, 2021ChemoCentryx Announces Filing of Amendment to NDA Submission and Extension of the PDUFA Review Period for Avacopan in the Treatment of ANCA-Associated Vasculitis
May  6, 2021ChemoCentryx Announces Results of FDA Advisory Committee Meeting on Avacopan in ANCA-Associated Vasculitis
Jul  9, 2020ChemoCentryx Submits New Drug Application to the U.S. FDA for Avacopan in ANCA-Associated Vasculitis

Further information

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