Core Insights - NICE has recommended sparsentan as the first non-immunosuppressive dual-action therapy for primary IgA nephropathy in eligible patients, marking a significant advancement in treatment options [1][2][3] - The recommendation is based on the positive results from the Phase 3 PROTECT trial, which demonstrated sparsentan's efficacy in reducing proteinuria compared to irbesartan [1][8] Company Overview - CSL Vifor is a global partner specializing in pharmaceuticals and innovative therapies, particularly in iron deficiency and nephrology, with a focus on strategic global partnerships and precision healthcare [3][4] - The company plans to launch sparsentan in the UK in the second half of 2025, with commercial stock expected to be available from July 2025 [2][6] Industry Context - IgA nephropathy is the most common type of primary glomerular disease worldwide, affecting over 22,000 adults in England, with a significant risk of kidney failure if not adequately treated [2][5] - Current treatment guidelines indicate that patients with persistent urine protein excretion greater than 1 g/day are at high risk for progressive chronic kidney disease, highlighting the need for effective therapies like sparsentan [2][5][8] Clinical Trial Insights - The PROTECT trial involved 404 patients and showed that sparsentan achieved a mean reduction in proteinuria of 49.8% after 36 weeks, compared to 15.1% for irbesartan [8] - The trial was notable for being one of the largest interventional studies in IgA nephropathy and the only head-to-head trial in this area [8] Regulatory Milestones - The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for sparsentan in April 2025, paving the way for its use in the NHS [1][3] - NICE's guidance mandates that sparsentan must be funded within 90 days of the final publication, expected on June 27, 2025 [1][2]