The UK National Institute for Health and Care Excellence (NICE) has recommended Vifor Fresenius Medical Care Renal Pharma’s Tavneos (avacopan) plus rituximab or cyclophosphamide to treat adults with two ANCA-associated vasculitis (AAV) forms.
The treatment is indicated for severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), which are the two forms of AAV.
Vifor anticipates launching Tavneos in the country in the coming weeks.
Patients in England, Wales and Northern Ireland can receive the first oral therapy for GPA/MPA with the new recommendation.
The latest development comes after the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted authorisation for the combination therapy in May this year.
Based on the complete development programme data, including findings from the Phase III ADVOCATE clinical trial that enrolled 331 AAV (GPA/MPA) patients in 20 countries, the NICE recommended the treatment.
The controlled, randomised trial assessed oral 30mg twice-a-day doses of Tavneos versus oral prednisolone on a tapering regimen.
According to the results, the trial met the primary endpoints of disease remission at week 26, described as a Birmingham Vasculitis Activity Score (BVAS) of 0 and not receiving glucocorticoids to treat AAV in the four prior weeks.
In addition, sustained remission was reported at weeks 26 and 52.
Developed by ChemoCentryx, Tavneos is an oral small molecule. It can selectively hinder the complement C5a receptor C5aR1.
Currently, Vifor has a licencing agreement in place with ChemoCentryx to market the therapy outside the US.
CSL Vifor chief medical officer Dr Klaus Henning Jensen said: “We are delighted about this recommendation for patients in England, Wales and Northern Ireland living with GPA/MPA.
“We look forward to continuing working with the National Health Service to ensure access to this important medicine for patients across the UK as quickly as possible.”