VFMCRP receives EU approval for Tavneos® for the treatment of ANCA-associated vasculitis
Vifor Fresenius Medical Care Renal Pharma announced that the European Commission has approved Tavneos® for treating severe, active ANCA-associated vasculitis, specifically granulomatosis polyangiitis (GPA) and microscopic polyangiitis (MPA). This approval aligns with the FDA's earlier decision in October 2021. Tavneos® will be available across all EU member states and in Iceland, Liechtenstein, and Norway, with initial launches projected for H1 2022. This approval is based on the successful phase-III ADVOCATE trial, demonstrating superior efficacy compared to standard treatments.
- European Commission approval of Tavneos® for ANCA-associated vasculitis enhances treatment options in Europe.
- Tavneos® demonstrated superiority in the phase-III ADVOCATE trial, enhancing clinical outcomes for patients.
- First launches expected in H1 2022, indicating a timely market entry.
- None.
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First orally administered therapy for the treatment of the two main types of ANCA-associated vasculitis approved in
Europe - First launches expected in H1 2022
“The European Commission’s approval of Tavneos® is a milestone for the treatment of ANCA-associated vasculitis in
“This is a significant step forward for patients in
EU approval is based on a comprehensive development program, culminating in the results from the pivotal phase-III trial ADVOCATE in 331 patients with ANCA-associated vasculitis in 20 countries, comparing treatment regimens including Tavneos® to current standard of care treatment regimens with high dose glucocorticoid use. 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). Tavneos® demonstrated superiority over standard of care at week 52.
About
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About ANCA-associated vasculitis
ANCA-associated vasculitis is a systemic disease in which over-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 kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants, in combination with glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.
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® arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of inflammation. Moreover, Tavneos® selective inhibition of only the C5aR1 leaves the beneficial C5a l pathway through the C5L2 receptor functioning normally.
Tavneos® was developed by
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Source: Vifor
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