The Food and Drug Administration has granted accelerated approval to Ultomiris, also known as ravulizumab, to reduce protein in the urine of adults with primary IgA nephropathy who are at risk of disease progression, AstraZeneca announced Oct. 21. In a Phase III trial, the drug lowered urine protein 43.4% more than placebo after 34 weeks. It has not yet been shown to slow the loss of kidney function.
IgA nephropathy is an immune-related kidney disease that affects more than 200,000 people in the U.S., according to the company. About half of patients with elevated urine protein or reduced kidney function are at high risk of end-stage kidney disease within 10 years of diagnosis. The disease occurs when an antibody called immunoglobulin A builds up in the kidneys' filters, causing inflammation and scarring over time, and many people first learn they have it after blood or protein shows up in a urine test.
