AstraZeneca Secures FDA Accelerated Approval for Ultomiris in IgA Nephropathy

AstraZeneca announced that the U.S. Food and Drug Administration granted accelerated approval for its Ultomiris therapy for adults with immunoglobulin A (IgA) nephropathy, a rare kidney disease.

Trial data

The decision follows an interim analysis of a late‑stage trial that showed a 43.4% reduction in proteinuria, the excess protein in urine, after 34 weeks compared with placebo. The study continues for a total of 106 weeks to evaluate whether Ultomiris can slow loss of kidney function, data that could support a traditional approval.

AstraZeneca noted that more than 200,000 people in the United States are affected by IgA nephropathy. It added that roughly half of patients with elevated urine protein levels or reduced kidney function face a high risk of progressing to kidney failure within ten years.

The company said the accelerated pathway was used because the trial results demonstrated a meaningful clinical benefit for a condition with limited treatment options.

Regulatory authorities have not yet issued a final decision on traditional approval, and the ongoing trial will inform future labeling.