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The treatment is the first FDA approved orally-administered inhibitor of the complement C5a receptor.
The US Food and Drug Administration (FDA) has approved avacopan (TAVNEOS) as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.
The orally administered selective complement 5a receptor inhibitor is specifically earmarked for granulomatosis with polyangiitis and microscopic polyangiitis, which are the 2 main forms of ANCA vasculitis, in combination with standard therapy.
The treatment, awarded to ChemoCentryx, represents the first FDA approved orally-administered inhibitor of the complement C5a receptor.
The approval was based on the data from the phase 3 ADVOCATE trial, a global, randomized, double-blind, active-controlled, double, dummy trial with 330 patients with ANCA-associated vasculitis in 20 countries. Participants were randomized to receive either rituximab or cyclophosphamide, followed by azathioprine/mycophenolate and either avacopan or study-supplied oral prednisone.
In addition, subjects could also receive non-protocol glucocorticoids if needed.
The investigators met the primary endpoint of disease remission at week 26 and sustained remission at week 52.
The treatment was superior to a prednisone-based standard of care with sustained remission at week 52.
The most common adverse reactions for the avacopan group included nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increase, and paresthesia.
The systemic autoimmune disease occurs when over-activation of the complement system further activates neutrophils, which leads to inflammation and the eventual destruction of small blood vessels, resulting in organ damage and failure, often in the kidney. The disease can be often fatal if not treated.
“The vasculitis community is elated that TAVNEOS is now approved, bringing a much-needed new treatment option to patients living with this devastating disease,” said Joyce Kullman, Executive Director, Vasculitis Foundation, in a statement. “There is a significant unmet need in the treatment of ANCA-associated vasculitis, with current therapies often leading to serious, even fatal, side effects and a diminished quality of life. We believe new therapies like TAVNEOS may offer a brighter future for these patients.”