The Therapeutic Goods Administration (TGA) in Australia has approved Vifor Fresenius Medical Care Renal Pharma (VFMCRP)’s Tavneos in combination with a rituximab or cyclophosphamide-based regimen for the treatment of adults with anti-neutrophil cytoplasmic autoantibody (ANCA) – associated vasculitis (granulomatosis polyangiitis [GPA] or microscopic polyangiitis [MPA]); two main forms of AAV.
Tavneos was granted orphan drug designation by the TGA and is the first targeted therapy for AAV and the first approved in a decade.
“This is a pleasing result, and we are committed to bringing this new treatment option to Australian patients living with AAV,” said James McDonnell, general manager, CSL Vifor Australia and New Zealand. “We expect to make a submission to the Pharmaceutical Benefits Advisory Committee as soon as possible, reinforcing our on-going commitment to improving the care of patients living with this rare disease.”
“This long-awaited new class of medication represents an important advancement for many patients living with AAV,” said Dr Daman Langguth, director of Immunology at Sullivan Nicolaides Pathology and clinical immunologist at Wesley Hospital. “We are confident that this novel therapy will provide more options to help control the disease, extend remission and meet major unmet medical needs in the treatment of AAV.”
The approval was based on a comprehensive development program, culminating in the results of the pivotal phase-III ADVOCATE trial, published in the New England Journal of Medicine, which was conducted in a total of 331 patients in 20 countries, including Australia. The study met its primary endpoints of disease remission at week 26 and sustained remission at week 52, as assessed by the Birmingham Vasculitis Activity Score (BVAS). The Tavneos-based regimen demonstrated superiority over standard of care at week 52.
The approval for Tavneos follows approvals in the US, Japan, the European Union (incl. Iceland, Liechtenstein and Norway), Canada, Great Britain, Switzerland and the United Arab Emirates. In Australia, Tavneos is commercialized under license from ChemoCentryx, Inc., a wholly owned subsidiary of Amgen, by VFMCRP through CSL Vifor (Vifor Pharma Pty Ltd), with availability in the second half of 2023.
