TAVNEOS (Avacopan) receives the approval of the European Commission as an oral add-on drug for the treatment of adult patients with severe GPA (granulomatosis polyangiitis) and MPA (microscopic polyangiitis). GPA and MPA are the two common types of ANCA-associated vasculitis (AAV). Its launch is expected this year.
Tavneos will be the first oral therapy approved for this disease in the European Union (EU). This drug has been authorized for oral use in combination with a regimen of cyclophosphamide or rituximab. It was earlier granted approval for the same indication by the Food and Drug Administration (FDA) of the US in October 2021. Vifor Fresenius Medical Care Renal Pharma (VFMCRP) confirmed that Tavneos (Avacopan) will get marketing authorization in Iceland, Norway, Liechtenstein, and the member states of the EU.
The approval of Tavneos is based on a comprehensive development program that culminated in the results of the pivotal phase-III trial ADVOCATE. It compared treatment therapies including Tavneos to the current standard of care treatment regimens with high dose glucocorticoid use in 331 patients suffering from ANCA-associated vasculitis in 20 countries. The Birmingham Vasculitis Activity Score was used to determine whether the research fulfilled its primary goals of disease remission at week 26 and sustained remission at week 52. Thus, Tavneos was found to be superior to the standard of treatment.
About ANCA-Associated Vasculitis
Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis is a cluster of rare autoimmune disorders that don’t have a specifically determined cause. It is mainly characterized by the necrosis (death) of blood vessels caused by inflammatory cell infiltration. The inflammation is mainly due to the anti-neutrophil cytoplasmic autoantibodies that bind to and overly activate neutrophils. Researchers have not yet established one particular cause of the disease. They believe that ANCA-associated vasculitis is a product of certain environmental and genetic factors.
About TAVNEOS (Avacopan)
Tavneos was initially developed by ChemoCentryx Ltd. It is a complement 5a receptor (C5aR) antagonist that inhibits C5a-mediated neutrophil activation and migration by blocking C5a-induced overexpression of C11b (integrin alpha M) on neutrophils. This drug has been linked to hypersensitivity events, such as angioedema, as well as hepatotoxicity, as demonstrated by increased liver transaminases. Tavneos has also been linked to hepatitis B virus reactivation and serious infections, which should be monitored as needed due to its influence on the complement pathway.
Thus, TAVNEOS (Avacopan) received orphan medicinal product designation by the European Commission to treat MPA, GPA, and C3 glomerulonephritis. It is available only in the form of capsules (oral use) of strength 10mg by a valid prescription.