With this recommendation, eligible patients in England, Wales and Northern Ireland will be able to access the first orally administered therapy for GPA/MPA, two main forms of ANCA-associated vasculitis (AAV)

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has announced 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.”