FDA Grants Accelerated Approval to Ultomiris for IgA Nephropathy

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ultomiris (ravulizumab) to reduce protein in the urine of adults with primary IgA nephropathy who are at risk of disease progression. In a Phase III trial, the drug demonstrated a 43.4% greater reduction in urine protein compared to placebo after 34 weeks. The trial is ongoing to determine if it slows the loss of kidney function, which would support traditional approval.