Canada OKs Tavneos as Add-on Treatment for MPA and GPA
Health Canada has approved the oral medicine Tavneos (avacopan) as an add-on therapy to treat adults with severe ANCA-associated vasculitis (AAV).
The approval specifically covers the use of Tavneos to treat granulomatosis polyangiitis (GPA) and microscopic polyangiitis (MPA), the two main types of AAV, in combination with standard background therapies (rituximab or cyclophosphamide) and glucocorticoids.
Health Canada’s approval follows similar approvals in the U.S. last year, and in the European Union earlier this year.
“On behalf of patients living with ANCA-associated vasculitis we are very happy with the approval of this life-changing treatment option,” Jon Stewart, president of Vasculitis Foundation Canada, said in a press release.
Initially developed by ChemoCentryx, Tavneos is an oral small molecule that works by blocking the activity of the complement cascade, a group of inflammatory proteins that are involved in the blood vessel inflammation that characterizes AAV. Otsuka Canada Pharmaceutical secured rights to market the therapy in Canada from Vifor Fresenius Medical Care Renal Pharma last year.
“We are very proud to be bringing this new treatment option to Canadian patients living with ANCA-associated vasculitis. The availability of [Tavneos], a first in class targeted treatment for ANCA-associated vasculitis, is highly anticipated in Canada as it represents an important advancement that will address clinical care gaps and extend remission,” said Michael Laranjo, president and general manager at Otsuka.
Health Canada’s approval of Tavneos was supported by data from a pivotal Phase 3 clinical trial called ADVOCATE (NCT02994927). The study enrolled 330 people with AAV, and participants were selected randomly to receive Tavneos or prednisone, a common glucocorticoid, in addition to standard background therapies.
Results showed that Tavneos effectively reduced disease activity after about one year of treatment, and outperformed prednisone in terms of improving kidney function for patients with severe kidney disease.
“Avacopan has now proven to be a new and integral cornerstone treatment for the induction of remission in patients with GPA and MPA, in addition to rituximab or cyclophosphamide. It is the first medication of its kind to allow for a substantial reduction in the use of glucocorticoids and may also provide additional benefits in terms of renal recovery,” said Christian Pagnoux, MD. Pagnoux is co-founder and president of the Canadian vasculitis research network CanVasc.
“This targeted therapy will be available for patients living with ANCA-associated vasculitis in Canada. Results from the Phase 3 ADVOCATE trial demonstrate that treatment with avacopan is not only very effective but also helps to minimize side effects by enabling replacement of a more traditional component of ANCA-associated vasculitis treatment,” added Louis-Philippe Girard, MD, a nephrologist in Calgary.
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