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
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