Australia’s Therapeutic Goods Administration (TGA) has granted approval for Vifor Fresenius Medical Care Renal Pharma’s (VFMCRP) Tavneos (avacopan) along with a rituximab or cyclophosphamide-based regimen to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.
The orally administered small molecule Tavneos is a selective inhibitor of the complement C5a receptor C5aR1.
It blocks the ability of those cells that do damage in response to the activation of C5a, which is known to be an inflammation driver.
The TGA has also granted orphan drug designation to Tavneos, which is claimed to be the first targeted therapy for AAV and the first to receive approval in ten years.
Tavneos has already been approved in Japan, Great Britain, the US, Switzerland, Canada, the United Arab Emirates, and the European Union, including Iceland, Liechtenstein and Norway.
CSL Vifor Australia and New Zealand general manager James McDonnell said: “This is a pleasing result, and we are committed to bringing this new treatment option to Australian patients living with AAV.
“We expect to make a submission to the Pharmaceutical Benefits Advisory Committee as soon as possible, reinforcing our ongoing commitment to improving the care of patients living with this rare disease.”
The TGA approval was supported by a comprehensive development programme, which includes the pivotal Phase III ADVOCATE trial data.
The trial was conducted with 331 participants in 20 countries, including Australia.
The Phase III trial achieved its main disease remission endpoints at week 26 and sustained remission at week 52, as evaluated by the Birmingham Vasculitis Activity Score (BVAS).
At week 52, the Tavneos-based regimen showed superiority over the standard of care in the study.
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