#United Kingdom #England #Sparsentan #FILSPARI #NICE

NICE Endorses FILSPARI® as a Treatment for IgA Nephropathy

A Landmark Decision

On May 23, 2025, the National Institute for Health and Care Excellence (NICE) made a groundbreaking recommendation endorsing FILSPARI® (sparsentan) as a treatment option for primary IgA nephropathy in adults within the NHS in England. This is a significant breakthrough for patients suffering from this chronic condition, especially those with high urinary protein excretion levels.

About IgA Nephropathy

IgA nephropathy is a progressive kidney disease characterized by the deposition of faulty immunoglobulin A (IgA) in the kidney's blood-filtering units, called glomeruli. This condition leads to inflammation, protein leakage, and, if untreated, can result in kidney failure. Currently, it is estimated that over 22,000 adults in England live with IgA nephropathy, and many experience a decline in kidney function over time. The disease often manifests in individuals around the age of 40, and up to 40% of those affected may progress to kidney failure within a decade if not adequately controlled.

NICE’s Evaluation Process

NICE's recommendation comes after rigorous evaluation of the Phase-III PROTECT trial results, which demonstrated that sparsentan significantly reduces proteinuria in patients compared to existing treatments like irbesartan. The trial followed 404 patients and provided compelling evidence that sparsentan achieves a mean reduction in proteinuria of nearly 50%. Given the potential it holds, NICE’s guidance requires that not only is sparsentan made available but also ensured that its use continues only for patients who respond positively to treatment.

The Role of Sparsentan

Sparsentan is unique as it is the first non-immunosuppressive dual-action therapy targeting both the endothelin A receptor and angiotensin II subtype 1 receptor. This dual action plays a crucial role in managing inflammation and kidney function, making it a valuable addition to IgA nephropathy treatment options. Moreover, the decision by NICE to recommend sparsentan signals a shift towards more innovative treatments in nephrology, where unmet needs remain substantial.

Response from Experts

Professor Jonathan Barratt, a leading specialist in renal medicine, commented on the NICE decision, labeling it a pivotal advancement for IgA nephropathy therapy in the UK. He stated that urgent and effective treatments are vital for improving patient outcomes in this difficult-to-manage disease.

Future Steps

CSL Vifor, the company behind sparsentan, plans to launch it in the UK by the latter half of 2025, expecting commercial availability from July. This strategic rollout follows the approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) earlier in April 2025.

Conclusion

The NICE guidance for FILSPARI® represents a hopeful future for many suffering from IgA nephropathy. As new therapies become available, awareness and continual research into kidney diseases will be paramount to ensure that patients receive the best possible care. The journey toward innovation in treating chronic kidney conditions like IgA nephropathy is ongoing, with exciting possibilities on the horizon for patients worldwide.