Sparsentan Approved: NICE Backs Kidney Disease Treatment
NICE now recommends sparsentan (Filspari) as a treatment for IgAN, a primary cause of chronic kidney disease. This endorsement reverses a previous rejection due to pricing concerns,opening a new treatment option for over 4,200 adults. The decision, based on new data and a discounted price, highlights sparsentan’s superior ability to reduce urine protein compared to standard treatments like irbesartan. This may lead to improved kidney function for patients with primary_keyword IgAN and reduce the need for kidney transplants. This is welcome news for those in the UK facing this leading cause of kidney failure, and marks a critically important win for the secondary_keyword chronic kidney disease community. News Directory 3 has all the details. discover what’s next for IgAN treatment and patient care.
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 The regulator’s final draft guidance recommends sparsentan for IgAN patients exhibiting a urine protein excretion of 1.0 gram per day or higher, or a UPCR of 0.75 g/g or higher.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.