CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.³ NICE has provided guidance to ensure that only patients responding to treatment continue.³ The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025.⁵

What this means in practice is that there is enough evidence to show that sparsentan provides benefits and value for money, so it can be used routinely if it is considered the most suitable treatment option in this population.³ Sparsentan must be funded in England within 90 days of final publication of this guidance³ which is expected to be 27 June 2025.

Professor Jonathan Barratt, Professor of Renal Medicine at University Leicester, UK, welcomed the NICE decision as a major advancement in the treatment of IgA nephropathy in the UK. "IgA nephropathy is a condition with an average age at diagnosis of around 40 years.⁶ Due to disease progression, a patient's kidneys may fail. Treatments, such as sparsentan, that have been developed for IgA nephropathy are urgently needed, our goal being to improve outcomes for these patients."

IgA nephropathy is characterised by the buildup of a faulty version of immunoglobulin A (IgA), which accumulates in clusters in small blood vessels in the kidney, called glomeruli, that filter the blood. These clumps damage the glomeruli causing leakage of blood (haematuria) and protein (proteinuria) into the urine resulting in a progressive loss of kidney function. Proteinuria is a major risk factor for IgA nephropathy progression, increasing the risk of kidney failure.^6-8 Despite current treatments, some patients with IgA nephropathy do not achieve adequate proteinuria reduction and remain at risk of progression.⁹

Although classified as rare, IgA nephropathy is the most common type of primary glomerular disease worldwide, with over 22,000 adults estimated to have the condition in England.¹⁰ Patients generally face a poor prognosis if the condition is not appropriately controlled, with approximately 30-40% of patients developing kidney failure within 10 years of diagnosis.¹¹

Current medical treatment guidelines by KDIGO (Kidney Disease, Improving Global Outcomes) state that patients who are at high risk of progressive chronic kidney disease, despite maximal supportive care, are those with persistent urine protein excretion >1 g/day.¹²

Underscoring the importance of the NICE recommendation for IgA nephropathy patients and their communities, Dr. 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. We look forward to working with the National Health Service to ensure access to this important medicine as soon as possible as we continue to deliver on our promise to patients."

CSL Vifor expects to launch sparsentan in the UK in the second half of 2025; commercial stock will be available from July 2025.