ST. GALLEN, SWITZERLAND-- August 18, 2022 -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is pleased to announce that England’s National Institute for Health and Care Excellence (NICE) has recommended Tavneos® in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), two main forms of AAV. The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.

“ANCA-associated vasculitis is a rare, systemic disease which can be rapidly fatal if not appropriately & promptly treated. The variable nature of the disease and its course along with challenging side-effects of current treatment options can severely affect subsequent quality of life for patients,” said John Mills, Vice-Chair of Vasculitis UK. “We very much welcome NICE’s decision, which means that eligible patients and clinicians have another choice of treatment for this debilitating condition.”

“NICE’s decision represents a major advancement for the treatment of GPA/MPA in the UK,” said Prof. David Jayne, Professor of Clinical Autoimmunity, University of Cambridge. “Patients will now have access to a new therapy option that could help them optimize their treatment outcomes.”

“We are delighted about this recommendation for patients in England, Wales and Northern Ireland living with GPA/MPA”, said Dr. Klaus Henning Jensen, Chief Medical Officer of CSL Vifor. “It means that an underserved patient population will have access to a first in class treatment aiming to meet major unmet medical needs. We look forward to continue working with the National Health Service to ensure access to this important medicine for patients across the UK as quickly as possible.”

MHRA approval and the NICE recommendation were based on findings from a comprehensive development program, culminating in the results from the pivotal phase-III trial (ADVOCATE) in 331 patients with ANCA-associated vasculitis (GPA/MPA) in 20 countries. This randomized, controlled trial assigned patients to either oral Tavneos® (30mg twice daily) or oral prednisolone on a tapering schedule. All patients received induction treatment with cyclophosphamide or rituximab. The study met its primary endpoints of disease remission at week 26, defined as Birmingham Vasculitis Activity Score (BVAS) of 0 at week 26 and not taking glucocorticoids for treatment of ANCA-associated vasculitis in the previous 4 weeks, and sustained remission at both weeks 26 and 52 defined as a BVAS of 0 and not taking glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to week 52. Compared to a prednisolone-based regimen, the Tavneos®-based regimen demonstrated non-inferiority in terms of remission at week 26, and superiority in terms of sustained remission at week 52. Serious adverse events (excluding worsening vasculitis) occurred in 37.3% of patients receiving Tavneos® and in 39% of those receiving prednisolone.