General Information

Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist.

Tavneos is specifically indicated as an adjunctive treatment of adult patients with severe active antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids.

Tavneos is supplied as a capsule for oral administration. The recommended dose is 30 mg (three 10 mg capsules) twice daily, with food. Advise patients that capsules should not be crushed, chewed or opened. If a dose is missed, instruct the patient to wait until the usual scheduled time to take the next regular dose. Instruct the patient not to double the next dose.

Mechanism of Action

Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a. Avacopan blocks C5a-mediated neutrophil activation and migration. The precise mechanism by which avacopan exerts a therapeutic effect in patients with ANCA-associated vasculitis has not been definitively established.

Side Effects

Adverse effects associated with the use of Tavneos may include, but are not limited to, the following:

• nausea
• headache
• hypertension
• diarrhea
• vomiting
• rash
• fatigue
• upper abdominal pain
• dizziness
• blood creatinine increased
• paresthesia

Clinical Trial Results

FDA approval was based on the results of the pivotal Phase III ADVOCATE trial. The ADVOCATE trial of Tavneos was a global, randomized, double-blind, active-controlled, double-dummy Phase III trial of 330 patients with ANCA-associated vasculitis in 20 countries. Eligible study subjects were randomized to receive either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate) and either Tavneos (avacopan) or study-supplied oral prednisone. Subjects in both treatment groups could also receive non-protocol glucocorticoids if needed. The study met its primary endpoints of disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score, or BVAS. The study demonstrated superiority to a prednisone-based standard of care with respect to sustained remission at 52 weeks.