NICE in England Endorses FILSPARI® for IgA Nephropathy Treatment

CSL Vifor has announced an important milestone in the treatment of IgA nephropathy, a significant cause of kidney failure, with the National Institute for Health and Care Excellence (NICE) in England recommending the use of sparsentan. This decision is based on positive outcomes from the phase-III PROTECT trial. Sparsentan, known for its dual-action non-immunosuppressive therapy, is now recommended for use in adults affected by primary IgA nephropathy with substantial proteinuria. This recommendation comes after approval by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

IgA nephropathy is a progressive kidney disease characterized by the accumulation of immunoglobulin A (IgA) in the kidney's glomeruli, leading to kidney damage and subsequent loss of kidney function. Despite existing treatments, many patients continue to experience severe proteinuria, which increases the risk of kidney failure. Current guidelines suggest that patients who continue to exhibit high levels of protein in their urine, despite supportive care, are at a high risk of disease progression.

The recent recommendation by NICE highlights sparsentan as a significant advancement in addressing the unmet medical needs of IgA nephropathy patients. Professor Jonathan Barratt from the University of Leicester emphasized the importance of this development, noting the urgency in improving patient outcomes in England, where over 22,000 adults are estimated to suffer from this condition. He points out that, without appropriate management, a large portion of these patients could face kidney failure within a decade of diagnosis.

Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor, expressed satisfaction with NICE's acknowledgment of sparsentan's value. The company plans to collaborate with the National Health Service to ensure timely access to this treatment, recognizing its potential to fill a critical gap in existing therapies.

The PROTECT trial, pivotal in NICE's recommendation, is the largest interventional study for IgA nephropathy, comparing sparsentan to irbesartan, an angiotensin II receptor blocker. Results from the trial demonstrated sparsentan's superior efficacy in reducing proteinuria among patients, along with a balanced safety profile compared to irbesartan. After 36 weeks of treatment, sparsentan showed a notable reduction in proteinuria compared to the control group, marking a significant therapeutic achievement.

Sparsentan functions as a dual antagonist of both the endothelin A receptor and angiotensin II subtype 1 receptor, mechanisms that play roles in kidney inflammation and damage progression. This innovative approach makes it the first non-immunosuppressive treatment option with such dual action for IgA nephropathy.

CSL Vifor, headquartered in St. Gallen, Switzerland, specializes in developing and marketing pharmaceuticals aimed at enhancing patient health globally. The company plans to launch sparsentan in the UK market by the latter half of 2025, with commercial availability expected in July. This development is anticipated to significantly improve the management of IgA nephropathy in England, offering new hope to individuals battling this challenging condition.