NICE Recommends⁣ Sparsentan for IgAN Treatment, Improving Kidney Function

Updated May 28, 2025

The National Institute for Health and Care Excellence (NICE) has endorsed sparsentan (Filspari, Vifor pharma) as a treatment option for adults with primary immunoglobulin A nephropathy ⁢(IgAN), a ⁢leading⁣ cause of chronic kidney disease.

This decision overturns NICE’s prior rejection of NHS funding for the drug, which was initially deemed not cost-effective. The manufacturer provided additional data and agreed to ⁢a discounted⁢ price, ‍leading⁣ to the revised recommendation for this IgAN treatment.

NICE noted ‍that sparsentan⁢ more effectively reduces the urine protein-to-creatinine ratio (UPCR) compared to standard treatments. The regulator’s final draft guidance recommends⁣ sparsentan for IgAN patients exhibiting a urine protein excretion of 1.0 gram ⁢per day or higher, or a UPCR of 0.75 g/g or higher.

Treatment should be discontinued after 36 weeks if a ‍patient’s UPCR remains at or above 1.76 g/g and has not decreased by at least 20%.

IgAN affects over 18,000 individuals in England and is a critically importent contributor to chronic kidney disease and kidney failure. It is indeed anticipated ‍that more than 4,200 people with chronic⁤ kidney disease could benefit from this NICE recommendation. Standard care typically involves angiotensin-2 receptor blockers like irbesartan.

Sparsentan functions by blocking receptors for endothelin-1 and ⁤angiotensin II, hormones that contribute to kidney damage.By⁢ blocking these receptors, ⁤the drug reduces proteinuria and slows the progression of kidney ⁢damage. Clinical trials, including the PROTECT study, have demonstrated that sparsentan reduces UPCR more effectively than irbesartan.

The PROTECT study, a phase 3 trial, involved patients with biopsy-proven primary IgAN and significant proteinuria despite renin-angiotensin system inhibition. Participants were randomly⁣ assigned⁢ to receive either 400 mg of sparsentan or 300 mg of irbesartan daily.

Results indicated that the sparsentan group experienced slower rates of estimated glomerular filtration rate (eGFR) decline. After 36 weeks, sparsentan considerably reduced proteinuria, a trend that continued throughout the study. At 110 weeks, proteinuria, measured⁣ by the change from baseline in UPCR, was 40% lower in the sparsentan group compared ‍to those ⁤receiving irbesartan.

Helen Knight, director of medicines evaluation at NICE, emphasized ⁣the limited treatment options ⁤for IgAN, ⁣stating that sparsentan offers long-term benefits and “could make a huge difference to people’s lives⁤ by delaying kidney⁤ failure.”

Fiona Loud, policy director at Kidney Care UK, welcomed the guidance, highlighting that⁢ IgAN often affects younger patients during critical life stages. “We’re pleased that this new treatment for IgAN ⁢will now be an option for patients who need it,” Loud said.

What’s next

With NICE’s recommendation, sparsentan is poised to become a more widely available treatment option, potentially reducing⁤ the need for dialysis or kidney transplants and alleviating pressure on the NHS.