The U.S. Food and Drug Administration (FDA) has granted accelerated approval of Vanrafia (atrasentan) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).
IgA Nephropathy
IgAN is a rare disorder that occurs when IgA accumulates in the kidneys. In the early stages, IgAN has no symptoms. The first sign of this condition may be blood in the urine. If left untreated, end-stage kidney disease may develop. In most instances, the cause of this condition is unknown; however, certain disorders have been linked with IgAN, such as cirrhosis of the liver, celiac disease, and HIV infection.
Atrasentan
Atrasentan is a potent, selective endothelin a (ETA) receptor antagonist that targets the reduction of proteinuria in adults with IgAN that are at risk of rapid disease progression. It is administered as a once-daily oral treatment that can be added on to supportive care.
Clinical Trial
The accelerated approval follows an interim analysis of the phase 3 ALIGN study (NCT04573478), a global, randomized, multicenter, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of atrasentan. The primary efficacy endpoint was change in proteinuria as measured by 24-hour UPCR from baseline to week 36. Secondary endpoints included change in kidney function from baseline to week 36 as well as safety and tolerability.
Based on data from the interim analysis, atrasentan has achieved statistically significant reductions of 36.1% in proteinuria at week 36 compared to placebo. These results were observed as early as week 6 and sustained through week 36. This effect was consistent across patient subgroups including age, sex, race, and baseline disease characteristics in the main study cohort. Additionally, similar effects were observed in a group of patients treated with both a RAS inhibitor and an SGLT2 inhibitor, with a 37.4% reduction in proteinuria at week 36 versus placebo.
Study results have also illustrated a favorable safety profile for atrasentan with adverse events reported in 2% or greater of patients. The most common adverse events include peripheral edema, anemia, and liver transaminase elevation.
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To learn more about IgAN and other rare kidney conditions, visit https://checkrare.com/diseases/kidney-and-urinary-diseases/
