Vifor Fresenius Medical Care Renal Pharma said that England's National Institute for Health and Care Excellence or 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 ANCA-associated vasculitis or AAV.
With the recommendation, eligible patients in England, Wales and Northern Ireland will be able to access the first orally administered therapy for GPA/MPA. It is expected to launch Tavneos in the UK in the next weeks.
The NICE's decision followed authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
GPA and MPA are the two main forms of ANCA-associated vasculitis which is a systemic disease in which inappropriate activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. It results in organ damage and failure, with the kidney and lung as major targets, and may be fatal if not treated.
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