Avacopan (Tavneos, ChemoCentryx) met its primary endpoints of disease remission at 26 weeks and sustained remission at 52 weeks during a phase 3 trial in patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.
The FDA approved avacopan (Tavneos, ChemoCentryx) for patients with severe active anti-neutrophil cytoplasmic autoantibody-associated (ANCA) vasculitis, according to a company press release.
“The vasculitis community is elated that Tavneos is now approved, bringing a much-needed new treatment option to patients living with this devastating disease,” Joyce Kullman, executive director at Vasculitis Foundation, said in the release. “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.”
Avacopan is the first FDA-approved orally administered inhibitor of the complement C5a receptor.
The FDA’s approval was based off the results of the phase 3 ADVOCATE trial, which met its primary endpoints of disease remission at 26 weeks and sustained remission at 52 weeks by the Birmingham Vasculitis Score.
The trial included 330 patients with ANCA vasculitis residing in 20 different countries. The patients were randomized to receive either rituximab or cyclophosphamide, followed by azathioprine/mycophenolate, and either avacopan or oral prednisone.
The most common adverse events were nausea, headache, hypertension, diarrhea, vomiting, and rash.
The results were highlighted in the February 2021 edition of The New England Journal of Medicine.
ChemoCentryx Announces FDA Approval of TAVNEOS™ (avacopan) in ANCA-Associated Vasculitis. ChemoCentryx. News release. October 8, 2021. Accessed on October 8, 2021. https://ir.chemocentryx.com/news-releases/news-release-details/chemocentryx-announces-fda-approval-tavneostm-avacopan-anca