Tavneos® (avacopan) included in updated EULAR recommendations for the management of AAV

• Tavneos^® newly introduced in the 2022 European Alliance of Associations for Rheumatology (EULAR) recommendations for the management of ANCA-associated vasculitis (AAV)
• Recommendations recognize Tavneos^®' ability to induce and sustain remission, lower glucocorticoids-induced toxic effects and potentially improve renal function in patients with GPA/MPA

ST. GALLEN, Switzerland, March 28, 2023 /PRNewswire/ -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is pleased to announce that Tavneos^® has been included in the revised EULAR AAV management recommendations, as one of several important updates in the 2022 version. As part of a strategy to substantially reduce exposure to glucocorticoids, Tavneos^® should be considered a therapy option in combination with rituximab or cyclophosphamide for induction of remission in patients with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two main forms of AAV.

The updated recommendations propose Tavneos^® as the strategy to substantially reduce the exposure to glucocorticoids (class IB recommendation). This recommendation recognizes Tavneos^®' ability to reduce exposure to glucocorticoids and lower glucocorticoid-induced toxic effects as measured by the Glucocorticoid Toxicity Index, while allowing patients to achieve and sustain remission. Furthermore, this recommendation acknowledges Tavneos^®' role in potentially improving kidney function as measured by glomerular filtration rate in patients with active glomerulonephritis and renal involvement.

"We are very pleased with the new AAV management recommendations and are grateful for this development for patients living with this systemic condition", said Fabio Dorigotti, Head Global Medical Affairs of CSL Vifor. "The inclusion of Tavneos^® is a clear endorsement of the benefit-risk profile of this therapy. We are confident that the updated recommendations will further strengthen the role of Tavneos^® in the management of AAV patients to achieve remission, with the potential to improve renal function while reducing the exposure and toxic effects associated to the prolonged use of high-dose glucocorticoids."

The results of the ADVOCATE study in 331 patients with ANCA-associated vasculitis are reflected in the 2022 update. The study met its primary endpoints of disease remission at week 26 and sustained remission at week 52, defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 and no receipt of glucocorticoids for 4 weeks before week 26/52. The Tavneos^®-based regimen demonstrated superiority over a prednisone-based regimen at week 52.

The EULAR recommendations for the management of AAV aim to provide practical, evidence-based recommendations for the diagnosis and treatment of AAV, thereby improving and harmonizing standards of diagnosis and treatment, and potentially improving quality of care. The recommendations are revised periodically, with the latest version presented at the European Congress of Rheumatology in June 2022 and published in the March 2023 issue of the Annals of the Rheumatic Diseases under: https://ard.bmj.com/content/early/2023/03/16/ard-2022-223764.

Tavneos^® is approved in the U.S., Japan, the European Union (incl. Iceland, Liechtenstein and Norway), Canada, Great Britain, Switzerland, United Arab Emirates and Australia.

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. 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 32,000 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.