Avacopan gets the tick as an adjunctive treatment for adults with granulomatosis with polyangiitis and microscopic polyangiitis.
The FDA has approved avacopan (Tavneos, ChemoCentryx) as an adjunctive treatment for adults with severe active ANCA-associated vasculitis.
It applies specifically to granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), the two main forms of ANCA vasculitis.
Avacopan’s approval for ANCA-associated vasculitis was supported by the results of the ADVOCATE trial, published in the New England Journal of Medicine. The global randomised, double-blind, active-controlled, double-dummy phase III trial of 330 patients with ANCA-associated vasculitis took place in 20 countries, including Australia.
Eligible study subjects were randomised to receive either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate) and either 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.
The most common adverse effects were: nausea, headache, hypertension, diarrhoea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increase and paraesthesia.
“I am excited that our work has helped lead to the first-in-a-decade approval of a medicine for ANCA-associated vasculitis. This is an important step forward in the treatment of this disease,” said the trial’s co-primary academic investigator Peter Merkel, chief of rheumatology at the University of Pennsylvania.
“Patients will now have access to a new class of medication that provides beneficial effects for the treatment of ANCA-associated vasculitis,” said Professor Merkel in a press release.
The drug is already approved in Japan and an application for approval is currently with regulators in Europe. An application for Avacopan listing in Australia is expected.
