NICE recommends treatment for chronic kidney disease, IgA nephropathy
Ella Day | May 23, 2025 | News story | Market & Product Development, Medical Communications, Research and Development | IgA nephropathy, National Institute for Health and Care Excellence, Nephrology, kidney disease
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending CSL Vifor’s FILSPARI (sparsentan) for the treatment of adults with primary IgA nephropathy in England. The guidance applies to patients with a urine protein excretion of 1.0g/day or more, or a urine protein-to-creatinine ratio of 0.75g/g or higher, with continued access dependent on treatment response.
FILSPARI is the first non-immunosuppressive, dual-acting therapy to be recommended by NICE for this indication. The decision follows marketing authorisation by the UK’s Medicines and Healthcare products Regulatory Agency in April 2025, and is based on findings from phase 3 PROTECT trial.
PROTECT compared sparsentan with irbesartan and met its primary endpoint at interim analysis, showing a 49.8% reduction in proteinuria versus 15.1% with irbesartan after 36 weeks. The safety profile was broadly balanced between treatment arms.
IgA nephropathy is a progressive form of chronic kidney disease and a leading cause of kidney failure. In England, around 22,000 adults live with the condition, with up to 40% experiencing kidney failure within ten years of diagnosis.
Commenting on the recommendation, Vinicius Gomes De Lima, head of global medical affairs at CSL Vifor, said: “We are very pleased that NICE recognised the value of our innovative therapy which helps to address a clear unmet medical need in patients with IgA nephropathy.”
NICE’s final guidance is expected to be published by 27 June 2025. Under NHS policy, FILSPARI must be made available in England within 90 days of final guidance.
Ella Day
23/5/25
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