Melbourne, Australia – 7 February 2023 – Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced the Therapeutic Goods Administration (TGA) in Australia has approved 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 52.1
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.by VFMCRP through CSL Vifor (Vifor Pharma Pty Ltd), with availability in the second half of 2023.
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 30,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, www.cslvifor.com.
About ANCA-associated vasculitis (GPA/MPA)
GPA and MPA are the two main forms of ANCA-associated vasculitis which is a systemic disease in which inappropriate activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidneys and lung as major targets, and may be fatal if not treated.
Historically. treatment of GPA/MPA has consisted of courses of potent immuno-suppressants, in combination with high-dose glucocorticoids (steroids) for prolonged periods of time. However, the unmet medical need remains high as these patients face significant risk of complications, both from their disease and adverse effects from medications, including from long-term use of glucocorticoids. Treatment goals are to achieve sustainable remission to reduce vascular damage and preserve organ function while minimizing the side effects of current treatments.
About Tavneos® (avacopan)
Tavneos® (avacopan)is an orally administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1. By blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment, C5a on inflammatory cells such as blood neutrophils, Tavneos® inhibits the ability of those cells to do damage in response to C5a activation, which is known to be the driver of inflammation. Moreover, the selective inhibition by Tavneos® of only the C5aR1 leaves other immune system responses functioning normally.
Tavneos® was developed by ChemoCentryx, Inc., a wholly owned subsidiary of Amgen, and is commercialized outside the US by CSL Vifor pursuant to a license agreement between VFMCRP and ChemoCentryx, Inc.
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