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

pharmafile | March 28, 2023 | News story | Business Services  

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.

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