NICE recommends sparsentan for IgA nephropathy

First non-immunosuppressive dual-action therapy approved for eligible patients

The National Institute for Health and Care Excellence (NICE) has recommended FILSPARI (sparsentan) for use in the NHS in England as a treatment for primary IgA nephropathy. The decision follows UK regulatory approval and is based on results from the phase 3 PROTECT trial.

NICE’s guidance states that sparsentan can be prescribed to 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. To ensure treatment efficacy, NICE has advised that only patients showing response should continue the therapy.

Professor Jonathan Barratt, professor of renal medicine at University Leicester, UK, welcomed the decision: “IgA nephropathy is a condition with an average age at diagnosis of around 40 years.

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, the most common primary glomerular disease worldwide, affects an estimated 22,000 adults in England. If uncontrolled, around 30-40% of patients develop kidney failure within 10 years.

Proteinuria is a significant risk factor, and some patients do not achieve adequate reduction with existing treatments, leaving them vulnerable to disease progression.

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, with commercial stock available from July.