A novel non-immunosuppressive therapy FILSPARI™ (sparsentan) has been granted approval by the U.S Food and Drug Administration to treat IgA nephropathy (IgAN).
Oral sparsentan is recommended to reduce proteinuria (protein in the urine) in patients at risk for disease progression because it targets the endothelin-1 and angiotensin 2 pathways, both of which promote IgAN disease progression. Having a urinary protein-to-creatinine ratio (UPCR) of 1.5 g/g or less is the standard definition of this condition.
The PROTECT Study is an ongoing phase 3 global, randomized, multicenter, double-blind, active-controlled clinical study that aims to evaluate safety outcomes and the effectiveness of sparsentan in slowing kidney deterioration. For patients with IgAN and proteinuria despite maximal tolerated angiotensin-converting enzyme (ACE) or angiotensin receptor blocker (ARB) therapy, researchers are comparing 400 mg of sparsentan to 300 mg of irbesartan.
After 36 weeks of therapy, Traverse reported in August 2021 that proteinuria had decreased with sparsentan by 49.8% from baseline. Only 15.1% of patients receiving an irbesartan-based treatment saw a mean decrease in proteinuria.
These preclinical findings imply that sparsentan met its pre-specified main efficacy endpoint, showing improvements in proteinuria that were clinically relevant and statistically significant. At the end of 2023, topline findings for the 2-year confirmation endpoints are anticipated, supporting the conventional FDA approval of sparsentan.
Peripheral swelling, hypotension and orthostatic hypotension, lightheadedness, hyperkalemia, and anaemia were the most typical adverse events (AEs) that occurred in 5% or more of patients. The medication is accessible through a Risk Evaluation and Mitigation Strategy (REMS) that has been authorized by the FDA because it may also increase the risk of liver damage and birth defects.
IgAN (Berger disease), a rare and progressive kidney condition that can result in kidney failure due to glomerular disease, affects nearly 150,000 individuals in the United States. Immunoglobulin A (IgA) protein accumulates in the kidneys, causing renal filtration to become worse, hematuria, proteinuria, and eventually kidney failure. This condition is known as IgAN.
