FDA Grants Accelerated Approval to Ultomiris for Primary Immunoglobulin A Nephropathy

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ultomiris (ravulizumab), developed by Alexion, AstraZeneca Rare Disease, for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. This marks the first and only C5 complement inhibitor approved for this indication, based on positive results from a Phase III trial showing a 43.4% reduction in proteinuria versus placebo at 34 weeks.