NICE has recommended Tavneos for sev., active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA) in combination with a rituximab or cyclophosphamide regimen in England, Wales & Northern Ireland
The recommendation was based on P-III (ADVOCATE) trial to evaluate Tavneos (30mg, BID) vs prednisolone in 331 patients with ANCA-associated vasculitis (GPA/MPA) across 20 countries. Tavneos is expected to be available in the UK in the next week
The study met its 1EPs of disease remission @26wk., sustained remission @26 & 52wk. & not using glucocorticoids within 4wks. before 52wk. The therapy also showed non-inferiority in terms of remission @26wks., and superiority in sustained remission @52wks., SAEs (37.3% vs 39%)
Ref: Businesswire | Image: CSL Vifor
